Performance-based preference for a novel xanthan gum-based thickener among clinicians treating dysphagia patients

Medical Speciality
Herentry K, et al. European Geriatric Medicine. 2011;2(S24-S206.).

Excellent Compliance1:
Does not affect colour, taste and odour of hot or cold liquids or foods.
  • Flavourless & Odourless
  • No lumps in various liquids
  • Practically transparent in water

  • 98% of professionals state that it helps improve compliance*



    Easy to Prepare6
    The results obtained with Resource® ThickenUp® Clear, Achieves a uniform level of viscosity in all hot or cold liquids.
  • Dissolves rapidly in all liquids
  • Same quantity for a given level of viscosity in all liquids

  • 8/10 professionals like how It prepares the right in-mouth consistency22



    Improve Swallowing Safety2-5
    Allows more effective treatment of swallowing difficulties.
  • Uniform viscosity, stable over time:
    Form a bolus without residues2
    Withstands salivary amylase3,7
    No over-thickening with time7
  • Fewer penetrations and aspirations2-4
  • Reduces the amount of oral and pharyngeal residue as compared to a starch-based thickening agent3

  • 80% of professionals prefer it over the thickening agents they recommended before6





    REFERENCES
    1. Effects of bolus rheology on aspiration in patients with dysphagia. Leonard RJ et al. J Acad Nutr Diet. 2014; 114(4): 590–594
    2. A comparative study between modified starch and xanthan gum thickeners in post stroke oropharyngeal dysphagia. Vilardell N et al. Dysphagia 2016; 31(2): 169–179
    3. The effects of a xanthan gum based thickener on the swallowing function of patients with dysphagia. Rofes L et al. Aliment Pharmacol Ther. 2014; 39(10): 1169–1179 4. Matching the rheological properties of videofluoroscopic contrast agents and thickened liquid prescriptions. Popa Nita S et al. Dysphagia 2013; 28(2): 245–252
    5. Acceptance, compliance and tolerance of a novel xanthan gum based thickener on oropharyngeal dysphagia patients. Hibberd J et al. Dysphagia 2011; 26: 432–475
    6. Performance-Based Preference for a Novel Xanthan Gum-Based Thickener among Clinicians Treating Dysphagia Patients. Nestlé Research Centre. Data on file 2011.
    7. Method of measuring amylase resistance properties of Resource® ThickenUp® Clear and a leading Thickening agent. Nestlé Research Center. Data on file 2009.
    Average: 4.3 (3 votes)
    Herentry K, et al

    Sensitivity and Specificity of the Eating Assessment Tool and the Volume-Viscosity Swallow Test for Clinical Evaluation of Oropharyngeal Dysphagia

    Medical Speciality
    Rofes L, Arreola V, Mukherjee R, Clavé P Neurogastroenterol Motil 2014 Sep;26:1256-65.

    Aim:
    To re-validate the accuracy of the Volume-Viscosity Swallow Test (V-VST) for Clinical Assessment by using a new thickening agent with an exclusive formula (ThickenUp® Clear) on 120 patients with oropharyngeal dysphagia associated with age and neurological pathology.

    Results:
    The study showed the V-VST using ThickenUp® Clear has high sensitivity in detecting patients with swallowing difficulty
  • Sensitivity of 0.94 and specificity of 0.88 in detecting oropharyngeal dysphagia
  • Sensitivity of 0.79 and specificity of 0.75 in detecting impaired efficacy
  • Sensitivity of 0.87 and specificity of 0.81 in detecting impaired safety
  • Sensitivity of 0.91 and specificity of 0.28 in detecting aspirations


  • Figure 12
    Test flow.


    Conclusion
    The V-VST is a validated method of Clinical Assessment of dysphagia, a sequence of 3 sizes of bolus of 3 different viscosities thickened with ThickenUp® Clear, is reliable in detecting and guiding management of patients with oropharyngeal dysphagia.
    Average: 3.5 (4 votes)
    Rofes L, et al

    Human Milk Oligosaccharides: New Ways to Shape the Gut Microbiome in Cows’ Milk Protein Allergy

    Medical Speciality
    Prof O’Mahony began by discussing how the human gut is colonised by a wide diversity of microbes. He went on to review the evidence for how they exhibit highly evolved synergistic relationships to provide essential biological functions to the host and how the gut microbiome is influenced by many factors in early life.
    Prof Renz proceeded to describe the importance of establishing a stable gut microbial community, which closely tracks host growth and immune development. The mechanisms whereby delays or alterations in the establishment of these communities can lead to microbiome immaturity, raise the risk of allergy development including cow’s milk protein allergy (CMPA).
    Dr Forbes-Blom introduced the multiplicity of human milk oligosaccharides (HMO) and explained their position as multifunctional components that shape the developing gut microbiome and influence the developing immune system.
    Finally, Prof Nowak Wegrzyn reviewed the latest trial data on supplementing specialty formulas for the management of CMPA with different HMO and reported the results.

    Read the full symposium notes here.






    IMPORTANT NOTICE: Mothers should be encouraged to continue breastfeeding even when their infants have cows’ milk protein allergy. This usually requires qualified dietary counselling to completely exclude all sources of cows’ milk protein from the mothers’ diet. If a decision to use a special formula intended for infants is taken, it is important to give instructions on correct preparation methods, emphasising that unboiled water, unsterilised bottles or incorrect dilution can all lead to illness. Formula for special medical purposes intended for infants must be used under medical supervision.
    Average: 2.8 (4 votes)
    Professor Liam O'Mahony
    Dr Harald Renz
    Dr Elizabeth Forbes-Blom
    Professor Ann Nowak-Wergrzyn

    Nestlé Health Science Scientific Publications Compendium 2018

    In 2018, Nestlé Health Science contributed to a number of scientific publications covering a broad spectrum of clinical conditions. We are now pleased to share with you this booklet, which summarises these publications as well as those contributed by the worldwide scientific community.

    As an innovative health science company, NHSc strongly believes in leveraging and investing in leading-edge science. We strive to forge a new industry, based on inherently safe nutritional therapies, which improve quality of life and provide clinical and health economic value. Our aim is to maximise the role of nutrition in empowering healthier lives.

    We also take this opportunity to thank all the experts involved in this work, namely healthcare professionals, institutions and Nestlé Health Science colleagues.

    Read the Scientific Compendium here
    Average: 3 (4 votes)
    Nestlé Health Science

    Hypoallergenicity of A Whey-Based, Extensively Hydrolysed Formula Containing Two Structurally Identical Human Milk Oligosaccharides

    Medical Speciality
    Abstract:
    To determine whether an extensively hydrolyzed formula (EHF) supplemented with two human milk oligosaccharides (HMO) was tolerated by infants with cow’s milk protein allergy (CMPA).

    Methods:
    A whey-based EHF (Test formula) containing 2′fucosyl-lactose (2′FL) and lacto-N-neotetraose (LNnT) was assessed for clinical hypoallergenicity and safety. The Control formula was a currently marketed EHF without HMO. Children with CMPA, aged 2 months to 4 years, were assessed by double-blind, placebo-controlled food challenges (DBPCFC) to both formulas, in randomized order. If both DBPCFC were negative, subjects participated in a one-week, open food challenge (OFC) with the Test formula. Symptoms and adverse events were recorded. Hypoallergenicity was accepted if at least 90% (with 95% confidence intervals) of subjects tolerated the Test formula.

    Results:
    Of the 82 children with CMPA that were screened, 67 (intention-to-treat [ITT] cohort—mean age 24.5 ± 13.6 months; range 2–57; 45 [67.2%] male) were randomized to receive either the Test or the Control formula during the first DBPCFC. Of these, 64 children completed at least one DBPCFC (modified intention-to-treat [mITT] cohort). Three children were excluded due to protocol deviations (per protocol [PP] cohort; n = 61). There was one allergic reaction to the Test, and one to the Control formula. On the mITT analysis, 63 out of 64 (98.4%; 95% CI lower bound 92.8%), and on the PP analysis 60 out of 61 (98.4%; 95% CI lower bound 92.5%) participants tolerated the Test formula, confirming hypoallergenicity.

    Conclusion:
    The whey-based EHF supplemented with 2′FL and LNnT met the clinical hypoallergenicity criteria and can be recommended for the management of CMPA in infants and young children.

    Read more about the clinical trial here





    Reference:
    1. Hypoallergenicity of a whey-based, extensively hydrolysed infant formula containing two human milk oligosaccharides: Anna Nowak-Wegrzyn, Laura Czerkies, Kemuel Reyes, Barbara Collins, Ralf G. Heine. Abstract presented at the annual EAACI congress in Lisbon June 1-5, 2019.






    IMPORTANT NOTICE: Mothers should be encouraged to continue breastfeeding even when their infants have cows’ milk protein allergy. This usually requires qualified dietary counselling to completely exclude all sources of cows’ milk protein from the mothers’ diet. If a decision to use a special formula intended for infants is taken, it is important to give instructions on correct preparation methods, emphasising that unboiled water, unsterilised bottles or incorrect dilution can all lead to illness. Formula for special medical purposes intended for infants must be used under medical supervision.
    Average: 3.8 (4 votes)
    Professor Anna Nowak-Wegrzyn
    Dr Laura Czerkies
    Kemuel Reyes
    Dr Barbara Collins
    Dr Ralf G. Heine

    The Cows' Milk Allergy-Related Symptoms Score (CoMiSS™): A Useful Tool in the Clinical Setting - Results from an Observational Study

    Medical Speciality
    Objectives and Study:
    The CoMiSS score was developed as an easy-to-use awareness tool for primary health care providers to increase the awareness of the most common symptoms of cow's milk protein allergy (CMPA) and the evolution of symptoms during a therapeutic intervention. The purpose of the study was to evaluate the score in infants with symptoms indicative of CMPA and to evaluate its usefulness in the clinical practice.

    Methods:
    The study took place in 4 European countries (Belgium (BE), Czech Republic (CZ), Germany (GER), United-Kingdom (UK)) and the dietary intervention was according to the current practice of the participating HCP in order to obtain “real world data”. CoMiSS was determined in 268 infants and young children (145 boys, 117 girls) aged 0-18 months at the first visit upon presenting symptoms suggesting CMPA and again after 3 weeks of a dietary intervention, with a cow milk protein free diet.

    Results:
    The characteristics, of the infants included, differed according to the country at first visit for age in weeks [mean ± SD] (12.7 ± 10.0 for BE; 24.1 ±14.2 for CZ; 21.4 ± 17.7 for GER; 34.1 ± 17.7 for UK) and duration of symptoms in weeks [mean ±SD] (6.9 ± 9.1 for BE, 11.5 ±10.4 for CZ, 9.7 ± 12.4 for GER and 24.0 ± 15.4 for UK ) In all countries, weight and height were in line with the reference growth chart and no growth failure was recorded before diagnosis. The median (IQR) CoMiSS score at inclusion was 11 (8-14) overall, 11 (8-14) in BE, 13 (12-16) in CZ, 8 (6-10) in GER and 7 (4-10) in UK. After 3 weeks of intervention per routine prescription the median (IQR) CoMiSS scores was 4 (2-6) and per country: BE 4 (2-6), CZ 3 (2-5), GER 4 (2-6), UK 3 (1-6). The scores after 3 weeks are in line with those considered as normal in healthy infants. At the first visit, 145/268 were prescribed medication for their symptoms with 35 (13%) taking one or more antacids. Additional medication was prescribed in 48 (18%), including 8 given a new prescription for an antacid. Data were analyzed per Intention to Treat and Per Protocol without notable differences.

    Conclusions:
    This study confirms that CoMiSS is a useful tool to increase the awareness of CMPA "in real life". Differences were noted between the four countries.




    Reference
    The cow's milk-related symptoms score (CoMiSS™): a useful tool in the clinical setting - results from an observational study. Yvan Vandenplas, Elisabeth Belsey, Anette Jarvi, Philippe Steenhout. Abstract presented at the annual ESPGHAN congress, June 6. JPGN Volume 68, Supplement 1, May 2019.






    IMPORTANT NOTICE: Mothers should be encouraged to continue breastfeeding even when their infants have cows’ milk protein allergy. This usually requires qualified dietary counselling to completely exclude all sources of cows’ milk protein from the mothers’ diet. If a decision to use a special formula intended for infants is taken, it is important to give instructions on correct preparation methods, emphasising that unboiled water, unsterilised bottles or incorrect dilution can all lead to illness. Formula for special medical purposes intended for infants must be used under medical supervision.
    Average: 2.8 (4 votes)
    Professor Yvan Vandenplas
    Elisabeth Belsey
    Dr Anette Jarvi
    Dr Philippe Steenhout

    Growth in Infants with Cows' Milk Allergy Fed an Amino Acid-Based Formula

    Medical Speciality
    Objectives and Study:
    To assess if an amino acid-based formula supports normal growth in infants with cow's milk protein allergy (CMPA).

    Methods:
    Infants aged 0-6 months with symptoms suggestive of CMPA (e.g. eczema, irritability, feeding problems, vomiting/regurgitation, persistent diarrhoea, rectal bleeding) were recruited from 10 clinical centres in China. After a baseline assessment, infants underwent a trial of an amino acid based formula (AAF; Alfamino®, Nestlé Health Science, Switzerland) for two weeks. In infants older than 4 months, a complementary, cow's milk protein-free diet was allowed during the trial. After 2 weeks on AAF, infants underwent an open food challenge (OFC) with a cow's milk-based infant formula (CMF; NAN®, Nestlé Nutrition, Switzerland). Those who reacted to CMF were diagnosed with CMPA and were offered to continue with AAF until 9 months of age (or until tolerant to cow's milk protein). Infants who tolerated CMF during the OFC underwent a one-week home challenge with CMF. Those who reacted during the home challenge phase were also classified as suffering from CMPA and allocated to treatment with AAF; tolerant infants remained on CMF and were discharged from the study. Birth weight and length were documented at enrolment. Growth parameters (body weight, length and head circumference) were measured at enrolment, after the AAF trial, and at final follow-up around 9 months of age. Weight-for-age, length-for-age and head circumference-for-age z scores (WAZ, LAZ, HCAZ) were calculated based on WHO growth standards.

    Results:
    Of 301 infants screened, 254 infants progressed to the AAF trial; 46 families withdrew early. Of the 254 infants who underwent the OFC, 150 (59.1%) were male; median age 16.1 weeks, interquartile range 9.9-20.3 weeks. 184 infants (72.4%) failed the OFC. Of the remaining 70 infants, 67 proceeded with an open 1-week CMF challenge at home. Of these, 43 (16.9%) reacted to CMF. A total of 227 infants (89.4%) were diagnosed as suffering from CMPA and remained on AAF and a cow's milk protein-free diet until 9 months of age. Follow-up data to the 9-month visit were available for 220 infants. Anthropometric data are summarised in Table 1. During the study period, mean body weight, length and head circumference increased in line with WHO growth standards, confirming normal growth velocity. Mean WAZ, LAZ and HCAZ were close to 0 (i.e. 50th WHO percentile), with maximum changes in z scores of less than 0.25 standard deviations (WAZ +0.23, LAZ +0.16, HCAZ +0.10) from enrolment to final visit.

    Conclusions:
    Infants with challenge-proven CMPA achieved normal weight gain, linear growth and head growth while being fed an amino acid-based formula, together with a cow´s milk protein-free elimination diet, during the first 9 months of life.




    Reference:
    Growth in infants with cow's milk protein allergy fed an amino acid-based formula. Yvan Vandenplas, Christophe Dupont, Philippe Eigenmann, Arne Høst, Mikael Kuitunen, Carmen Ribes-Koninkx, Neil Shah, Hania Szajewska, Andrea von Berg, Rajat Mukherjee, Ralf G. Heine, Zhengyan Zhao, on behalf of the Chinese Investigator Team. Abstract presented at the annual ESPGHAN congress, June 6. JPGN Volume 68, Supplement 1, May 2019.





    IMPORTANT NOTICE: Mothers should be encouraged to continue breastfeeding even when their infants have cows’ milk protein allergy. This usually requires qualified dietary counselling to completely exclude all sources of cows’ milk protein from the mothers’ diet. If a decision to use a special formula intended for infants is taken, it is important to give instructions on correct preparation methods, emphasising that unboiled water, unsterilised bottles or incorrect dilution can all lead to illness. Formula for special medical purposes intended for infants must be used under medical supervision.
    Average: 5 (3 votes)
    Professor Yvan Vandenplas
    Professor Christophe Dupont
    Professor Philippe Eigenmann
    Professor Arne Høst
    Dr Mikael Kuitunen
    Dr Carmen Ribes-Koninkx
    Dr Neil Shah
    Professor Hania Szajewska
    Dr Andrea von Berg
    Dr Rajat Mukherjee
    Dr Ralf G. Heine
    Dr Zhengyan Zhao
    on behalf of the Chinese Investigator Team

    Nestlé Health Science Scientific Publications Compendium 2017

    In 2017, Nestlé Health Science contributed to a number of scientific publications, covering a broad spectrum of the clinical conditions our company focuses on. This booklet highlights these publication summaries.

    As an innovative health science company, we strongly believe in investing in and leveraging leading-edge science. We strive to forge a new industry based on inherently safe nutritional therapies, which bring relevant quality of life benefits and proven clinical and health economic value. Our aim is to fully leverage the role of nutrition in changing the course of health for consumers and patients.

    Thank all the experts involved in this work, namely Healthcare Professionals, Institutions and Nestlé Health Science colleagues. Our meaningful scientific partnership will positively impact patients and consumers’ lives.

    Read the full Scientific Compendium here.
    Average: 2.2 (5 votes)
    Nestlé Health Science

    Modulen® IBD - Reaching New Heights with Clinical Evidence

    Medical Speciality
    This following shows a non-extensive list of the key clinical evidence behind Modulen® IBD. You will find a chronological summary of all the data collected and published over recent years that demonstrate the safety and efficacy of this product in Crohn’s Disease. Modulen® IBD is the only enteral product with extensive clinical evidence in Crohn’s Disease. All these studies have greatly contributed to the issuing of recommendations by several International and National Associations to use exclusive enteral nutrition as a primary form of intervention in Crohn’s Disease.

    1. Mucosal Healing
    And a fall in mucosal pro-inflammatory cytonkine mRNA induced by a specific oral polymeric diet in paediatric Crohn's Disease
    Fell JM, Paintin M, Arnaud-Battandier F, Beattie RM, Hollis A, Kitching P, Donnet-Hughes A, MacDonald TT, Walker-Smith JA. (2000) Aliment Pharmacol Ther. 14(3):281-9.

    Background
    Although enteral nutrition is a recognised form of treatment for intestinal Crohn’s Disease (CD), there are persistent problems with palatability and data are limited as to its mode of action.

    Objective
    In this prospective study, the effects of Modulen® IBD on the mucosal inflammatory process were evaluated in 29 children with active intestinal CD. All children were treated with Modulen® IBD as the sole source of nutrition for 8 weeks. Outcomes include clinical remission (defined as PCDAI <10), weight gain, endoscopic and histologic response, and markers of inflammation (CRP, TNF- ). Cytokine mRNA was measured in mucosal biopsies before and after treatment by quantitative reverse transcriptase polymerase chain reaction.

    Results
    • 96% of patients managed to take the polymeric formula orally
    • The median PCDAI, initially at 30 declined to a median of 25 at 8 weeks (p < 0.00001).
    • Children gained weight in response to treatment (mean weight gain at 8 weeks 3.2 kg, p < 0.001).
    • After 8 weeks, 79% of children were in complete clinical remission (PCDAI <10).
    • Macroscopic and histological healing in the terminal ileum and colon were associated with a significant decline in ileal and colonic IL-1ß mRNA (p = 0.006).
    • IFN- mRNA before treatment was elevated in the ileum and colon when compared with controls (p = 0.004, p = 0.001). Levels fell in the ileum in response to treatment, with a ratio of pre- to post-treatment IFN- mRNA of 0.15 (p < 0.001). On the other hand, ileal TGF-ß1 mRNA rose with treatment (ratio 10, p = 0.04). In the colon there was no significant change in either IFN- or TGF-ß1 mRNA in response to treatment.
    • In the colon IL-8 mRNA fell with treatment (ratio 0.06, p < 0.05).
    • Over the 10 months follow-up period 9/23 cases (39%) who had achieved a clinical remission (PCDAI <10) relapsed (defined as a rise in PCDAI above 10).

    Conclusion
    The clinical response to Modulen® IBD is associated with mucosal healing and a down- regulation of mucosal pro-inflammatory cytokine mRNA in both the terminal ileum and colon. In the ileum there is also an increase in TGF-ß1 mRNA.



    2. Effect of Enteral Nutrition
    On Antioxidant Enzyme Systems and Inflammation in Paediatric Crohn's Disease
    Phylactos AC, Fasoula IN, Arnaud-Battandier F, Walker-Smith JA, Fell JM. (2001) Acta Paediatr. 90(8):883-8.

    Background
    Crohn’s Disease (CD) is characterised by chronic inflammation of the gastrointestinal mucosa, which can be successfully treated with enteral nutrition. The activity of the antioxidant metallo- enzymes is significantly lower in children with CD than healthy children..

    Objective
    The purpose of this prospective study was to understand the mechanism of action of EN by assessing whether EN restores the activities of the antioxidant metalloenzymes copper/zinc- superoxide dismutase (Cu/Zn-SOD) and selenium-glutathione peroxidase (Se-GPx) in children with active CD. Children with active CD (PCDAI>10) (n=14) were treated with Modulen® IBD as the sole source of nutrition for 8 weeks. Measured outcomes include clinical remission (defined as PCDAI <10), antioxidant metalloenzymes, Cu/Zn-SOD and Se-GPx, and markers of inflammation (CRP and TNF- ).

    Results
    • In response to treatment, 13/14 patients went into complete remission. Overall, the PCDAI fell from an initial median of 26 to 0 (p < 0.001).
    • Patients treated with Modulen® IBD did not have significantly altered Cu/Zn-SOD and Se-GPx enzyme activities.
    • CRP fell from a median of 20 to 1.0 mg/L (p < 0.001), and serum TNF- from a mean of 12.8 pg/mL to 9.6 pg/mL (p < 0.05).

    Conclusion
    The results imply that the anti-inflammatory action of enteral nutrition in CD is caused by a mechanism other than restitution of these antioxidant enzymes.



    3. Nutritional therapy Alone
    With a Polymeric Diet (Modulen) is More Effective Than Corticosteroids in Inducing Healing of Intestinal Mucosal Lesions in Active Crohn's Disease
    Bascietto C, Borrelli O, Di Nardo G, Ambrosini A, Cirulli M, Bosco S, Cucchiara S. (2004) J Pediatr Gastroenterol Nutr. 39 Suppl 1:S106-7.

    Background
    Therapy of active Crohn’s Disease (CD) should be aimed at obtaining clinical remission, improving quality of life and healing gut inflammatory lesions. The latter is a critical factor to provide long term remission. Traditional treatment for active paediatric CD includes corticosteroids or nutritional therapy alone; however, very few studies have compared the two treatment regimens taking into account inflammatory lesions of the gut as documented by endoscopy and histology.

    Materials and Methods
    This prospective study compared the efficacy of an oral polymeric diet (Modulen® IBD), rich in Transforming Growth Factor ß2, versus oral corticosteroids in inducing clinical and inflammatory remission in children with a newly diagnosed or relapsed CD. Thirty-two children with CD were randomised to receive either a Polymeric diet (n=17) (Modulen® IBD) exclusively for 10 weeks or oral corticosteroids (methylprednisolone 1.6 mg/kg/day and azatioprine) (n=15) for 4 weeks. Outcomes measured include clinical remission rate (PCDAI <10) and inflammatory remission which was defined as a decrease in both endoscopic and histological scores by more than 50% when compared to baseline.

    Results
    • The PCDAI improved both in the nutrition group and steroid group (p < 0.01 for both groups compared to baseline).
    • However, endoscopic and histologic score significantly decreased only in the nutrition group (p < 0.01), whereas no significant change was observed in the steroid group
    • Inflammatory remission was obtained in 82.35% of the patients on enteral nutrition and only in 40% of the patients on steroids (p < 0.01) (Fig).


    Conclusion
    In children with active CD, exclusive treatment with an oral polymeric diet is as efficacious as an oral corticosteroid course in inducing clinical remission. However, only nutrition therapy was shown to promote healing of gut inflammatory lesions as evidenced by endoscopy and histology scores. This is also in line with NICE Crohn’s disease management in adults, children and young people (Oct 2012) where mucosal healing may be better following treatment with enteral nutrition. Exclusive nutrition therapy is therefore a recommended treatment of choice in children with active CD. Modulen® IBD therapy may aid in mucosal healing.



    4. Colonic Crohn's Disease
    In Children Does Non Respond Well to Treatment with Enteral Nutrition if the Ileum is not Involved
    Afzal NA, Davies S, Paintin M, Arnaud-Battandier F, Walker-Smith JA, Murch S, Heuschkel R, Fell J. (2005) Dig Dis Sci. 50(8):1471-5.

    Background
    Data supporting a response to treatment with exclusive enteral nutrition in paediatric colonic Crohn’s Disease (CD) are scarce.

    Materials and Methods
    This prospective study evaluated the changes in clinical and biochemical responses of ileal, colonic, and ileocolonic CD in 65 children with acute intestinal CD (PCDAI >20). The children were distributed into 3 groups:
    • Colonic (n=14): involvement of any colonic location between the cecum and rectum with no small bowel or upper gastrointestinal involvement.
    • Ileal (n=12): limited to the ileum, with or without spillover into the cecum.
    • Ileocolonic (n=39): ileal disease and involvement of any colonic location between the ascending colon and the rectum.
    All children received exclusive Modulen® IBD as treatment at a rate of 110-120% of the recommended daily allowance. Outcomes measured include endoscopic inflammation (0 to 3 scale), histological inflammation (0 to 3 scale), and remission defined as PCDAI < 20.

    Results
    • At enrolment, the ileal group had significantly less severe disease (p = 0.05) compared to the colonic and ileocolonic groups.
    • However, the smallest decrease in PCDAI scores at completion of treatment with enteral nutrition was observed in the colonic disease group (p = 0.03). The colonic disease group also had the lowest remission rate (50% vs. 82.1% in the ileocolonic and 91.7% in the ileal group) (p = 0.021).
    • Endoscopic and histologic colonic mucosal assessment showed a post-treatment improvement in the ileocolonic (p ≤ 0.01) but not in the colonic disease group (p = NS) (Table).

    Table: Comparison of the colonic histologic and endoscopic scores in the ileocolonic and colonic groups shows significant improvement in the ileocolonic but not in the colonic group

    Conclusion
    Children with ilecolonic disease respond better to EN therapy than those with solely colonic or ileal involvement.



    5. Energy Intakes of Children
    With Crohn's Disease Treated with Enteral Nnutrition as Primary Therapy
    Gavin J, Anderson CE, Bremner AR, Beattie RM. (2005) J Hum Nutr Diet. 18(5):337-42.

    Background
    Enteral nutrition (EN) is widely used and is effective in the treatment of children with Crohn’s Disease (CD) when given as an exclusive feed for 6-8 weeks. Current dietetic practice during EN is to recommend an energy intake based on the estimated average requirement (EAR) for energy according to age.

    Materials and Methods
    In this retrospective study, factors affecting energy intake and weight gain during EN in relation to disease site and nutritional status were examined. Forty children with CD were treated with Modulen® IBD alone for 8 weeks. Outcomes measured include weight gain, CRP (inflammatory marker), and energy intakes compared to EAR.

    Results
    • All patients gained weight during EN (median percentage weight gain is 11%).
    • All patients showed a significant improvement in the CRP levels, suggesting a decrease in inflammatory response (p < 0.0001).
    • Energy intake was higher than EAR in 82% of patients with a median of 117.5% of EAR.
    • Weight gain correlated with Body Mass Index Standard Deviation Score (BMI SDS) (p = 0.001) at the start of treatment, but not energy intake or CRP. Those with lower BMI SDS at the start of treatment gained more weight during exclusive EN.
    • No statistically significant differences in outcomes were seen in relation to disease site (small bowel, ileocolonic or colonic).


    Conclusion
    EN allows children with CD to gain weight in correlation with the BMI standard deviation score at the start of treatment. Energy intakes may be underestimated by EAR in children newly diagnosed with CD. Therefore, energy intakes of 100-149% EAR may be required.



    6. Enteral Nutrition and Microflora
    In Pediatric Crohn's Disease
    Lionetti P, Callegari ML, Ferrari S, Cavicchi MC, Pozzi E, de Martino M, Morelli L (2005) JPEN. 29 (4 Suppl):S173-5; discussion S175-8, S184-8.

    Background
    Exclusive enteral nutrition (EN) is an established primary therapy for paediatric Crohn’s Disease (CD). The mechanism of action of such treatment is still conjectural. Proposed mechanisms have included the elimination of dietary antigen uptake, overall nutrition repletion, provision of important micronutrients to the diseased intestine, correction of abnormal intestinal permeability, and immunological downregulation.

    Materials and Methods
    The purpose of this prospective study was to determine if EN-induced remission is associated with modification of fecal microflora in CD. Five healthy children and nine children with active CD were enrolled in the study. The children with active CD received Modulen® IBD only (n=9) for 8 weeks. At the end of the exclusive EN course, children returned to a free diet but continued to take 40% of daily caloric intake as polymeric formula. Eight of the nine patients also received the immunosuppressive agent 6-mercaptopurine. Outcomes measured include clinical remission (PCDAI <15) and fecal microflora.

    Results
    • In 8 of 9 children (88%), the exclusive EN alone induced disease remission (PCDAI <15) within 2 weeks of exclusive diet (Fig). All children were in disease remission after 4 weeks of exclusive EN.
    • After the 8-week course of an exclusive liquid diet, patients on partial EN were followed up for a period ranging from 2 to 8 months. All patients maintained disease remission during the follow-up period.
    • Profound changes in fecal microfora profiles were observed after treatment with exclusive EN compared to baseline.
    • In contrast, control healthy children showed a host-specific and stable fecal microflora over time.


    Conclusion
    A possible mechanism of action of EN in inducing disease remission in CD may be its capacity to alter gut microflora.



    7. Polymeric Diet Alone
    Versus Corticosteroids in the Treatment of Active Pediatric Crohn’s Disease: a Randomized Controlled Open-Label Trial
    Borrelli O, Cordischi L, Cirulli M, Paganelli M, Labalestra V, Uccini S, Russo PM, Cucchiara S. (2006) Clin Gastroenterol Hepatol. 4(6):744-53.

    Background
    Nutrition therapy has been reported to have an almost equivalent efficacy as corticosteroids in achieving clinical remission in active Crohn’s Disease (CD). However, the effects of both treatments on intestinal mucosal inflammation are rarely reported.

    Objective
    The purpose of this prospective study was to compare the efficacy of exclusive nutrition therapy or corticosteroids on clinical variables and intestinal mucosal healing.
    Thirty-seven children diagnosed with CD were randomised in an open-label trial to receive either Modulen® IBD alone (n=19) or oral corticosteroids (methylprednisolone) (n=18) for 10 weeks. Clinical remission (PCDAI <10) and mucosal healing (defined as a decrease in both endoscopic and histologic scores by 50% or more) outcomes were measured.

    Results
    • At week 10, the proportion of patients achieving clinical remission was comparable between the 2 groups (Modulen® IBD: 79%; corticosteroid group: 67%) (p = 0.4) (Fig).
    • On the contrary, the proportion of children showing mucosal healing was significantly higher in the Modulen® IBD (74%) than in the corticosteroid group (33%) (p < 0.05).
    • At week 10, both endoscopic and histologic scores significantly decreased only in the Modulen® IBD group (p < 0.001).


    Conclusion
    In children with active and recently diagnosed CD, a short course of polymeric diet is more effective than corticosteroids in inducing healing of gut inflammatory lesions.



    8. The Use of Exclusive
    Enteral Nutrition for Induction of Remission in Children With Crohn’s Disease Demonstrates that Disease Phenotype Does Not Influence Clinical Remission
    Buchanan E, Gaunt WW, Cardigan T, Garrick V, McGrogan P and Russell RK (2009) Aliment Pharmacol Ther. 30: 501-507.

    Materials and Methods
    The purpose of this prospective study was to describe the centre’s experience of treating CD with a primary course of enteral nutrition and factors affecting treatment outcome. One hundred and fourteen children with CD were treated with either Modulen® IBD (n=105) for 8 weeks or with Elemental E028 extra (SHS international, Liverpool , UK) (n=5) for 8 weeks. Disease remission was assessed by several outcomes including patients’ well being, weight gain, stool frequency and inflammatory markers (CRP, ESR).

    Results
    • 52% of patients took feeds orally, 45% via nasogastric tube and 2% via PEG and 75% of patients completed at least 7 weeks of treatment.
    • Clinical remission was achieved in 80% of patients.
    • A significant decrease in both the median ESR and CRP at the start and end of treatment (38 vs. 13 and 22 vs. 6, respectively p < 0.001 for both) was observed in patients in clinical remission.
    • Patients in clinical remission had significant improvements in weight and BMI Z scores at the end of the treatment (P< 0.001).
    • The clinical remission rate in patients with isolated colonic disease was not different compared to other disease locations (77% vs. 79%, p = 0.88).


    Conclusion
    Enteral nutrition is well tolerated and results in clinical remission, normalisation of inflammatory markers, together with significant improvements in weight/BMI z-score in most patients. Clinical remission is not influenced by CD location suggesting enteral nutrition should be offered to all patients regardless of disease phenotype at diagnosis.



    9. The Efficacy of Exclusive
    Nutritional Therapy in Paediatric Crohn’s Disease, Comparing Fractionated Oral vs. Continuous Enteral Feeding
    Rubio A, Pigneur B, Garnier-Lengliné H, Talbotec C, Schmitz J, Canioni D, Goulet O, Ruemmele FM (2011) Aliment Pharmacol Ther. 33:1332-1339

    Background
    Nutritional therapy has an established role as induction therapy in paediatric Crohn’s Disease (CD). However, patient compliance is an important challenge and may be greatly influenced by the administration route.

    Materials and Methods
    The objective of this study was to compare the efficacy of exclusive fractionated oral vs. continuous enteral feeding in inducing remission in children with CD. In this retrospective study, medical records of 106 children with active CD (PCDAI >10) were reviewed. All children were treated with Modulen® IBD as the sole source of nutrition for 8 weeks. The two comparative groups were oral intermittent or continuous enteral route by NG tubing. The primary outcome: Clinical remission defined as PCDAI <10.

    Results
    • At 8 weeks, 34/45 patients achieved remission in the oral group (75% on intention-to-treat analysis) and 52/61 (85%) in the enteral nutrition group (P = 0.157) (Fig).
    • All patients showed a significant decrease in disease severity assessed by PCDAI (P < 0.0001) and significant improvements in anthropometric measures and inflammatory indices.
    • Mucosal healing was observed and showed high correlation with remission.


    Conclusion
    Fractionated EN was shown to be as effective as oral nutritional therapy in inducing CD remission. All patients showed a significant decrease in disease severity and significant improvements in anthropometric measures and inflammatory indices. No differences were observed between Modulen IBD administered orally or by continuous enteral feeding, apart from weight gain which is greater in the enteral group. In a subgroup of patients (those who accepted follow-up endoscopy), mucosal healing was evident on follow-up endoscopies showing a clear correlation with remission. Compliance rates (87% oral group and 90% enteral group) were similar. Nevertheless, noncompliant patients had lower mucosal healing and remission rates.
    Nutritional therapy based on the exclusivity principle is highly efficacious in inducing remission and mucosal healing in paediatric CD.



    10. Influence of Exclusive
    Enteral Nutrition Therapy on Bone Density and Geometry in Newly Diagnosed Paediatric Crohn’s Disease Patients.
    Werkstetter KJ, Schatz SB, Alberer M, Filipiak-Pittroff B, Koletzko S (2011) JPGN. 52, (Suppl 2), E212.

    Background
    Paediatric Crohn’s Disease (CD) patients often present with deficits in muscle mass and bone quality at diagnosis and during follow-up. Exclusive enteral nutrition (EEN) induces remission and may have positive effects on muscle and bone.

    Materials and Methods
    The aim of this prospective study was to follow the development of muscle and bone in paediatric CD patients (n=10) initially treated with EEN (Modulen® IBD was given for 8 weeks, no steroids were applied) in the first year after diagnosis using peripheral quantitative computed tomography (pQCT).
    Primary outcomes measured include disease activity (measured by PCDAI), bone mineral density: pQCT (XCT 2000, Stratec Inc.) at the non-dominant forearm (distal at 4%-site, proximal at 65%-site) and bone and muscle parameters: Trabecular (TrbD) & Cortical Density (CrtD), Total Cross Sectional Area (TotalCSA), Muscle Cross Sectional Area (MuscleCSA).

    Results
    • Disease activity decreased after EEN therapy.
    • Low TrbD z-scores increased until week 12 (+0.3; (0.0-1.0); p=0.006) (Fig. 1).
    • High CrtD z-scores normalised until week 12 (-0.4 (-1.1-0.5); p=0.027), but increased again between week 24 to 52.
    • Z-scores of height corrected TotalCSA increased until week 12 (+0.2 (-0.2-0.6);p=0.014).
    • Low height corrected MuscleCSA z-scores improved (+1.0 (0.6-1.8); p=0.002) until week 12 but remained on a low level compared to reference (Fig. 2).


    Conclusion
    Low trabecular and high cortical bone density at diagnosis indicate disturbed bone remodelling. MuscleCSA is significantly impaired at diagnosis. Within 3 months after initiation of EEN therapy, bone metabolism and muscle mass significantly improve towards normalisation.



    11. Two-Year Prospective Audit
    Of Use of Liquid Diets as “Bridge” Therapy for Active Crohn’s Disease.
    Demetriou T, Gawad C, Kok C, Harris AW, Gut (Supplement), March 2008;57:A1-A172

    Background
    Patients with active CD were prospectively recruited between April 2005 and August 2007.

    Materials and Methods
    Patients received Elemental E028 (SHS international , Liverpool UK) during the initial 8 months followed by Modulen® IBD for the remaining period. Exclusive enteral nutrition was followed for 4 weeks. Clinical response was assessed in clinic around day 28.

    Results
    • E028 was used in 13 patients, only 54% managed to complete 28 days treatment.
    • Out of the Modulen® IBD group 69% managed to complete the 28 day treatment.
    • Clinical remission was achieved in 6/7 in the E028 and in 9/9 in the Modulen® IBD group.


    Conclusion
    On an intention to treat (ITT) analysis a clinical response was achieved in 69% in the Modulen® IBD vs. 54% in the E028 group. Adherence can be achieved with well-motivated and supported patients. The use of liquid diets to avoid the use of steroids and to act as a “bridge” to allow the onset of action of thiopurine or methotrexate appears practical and effective.



    12. Beneficial Effect
    Of a Polymeric Feed, Rich In Tgf-Β, On Adult Patients With Active Crohn’s Disease: A Pilot Study.
    Trianfillidis JK, Stamataki A, Gikas A, Sklavaina M, Mylonaki M, Georgopoulos F, Mastragelis A, Cheracakis P, Ann Gastroenterology 2006:19(1):66-71

    Background
    29 patients with active CD were treated with exclusive enteral nutrition using Modulen® IBD (50g x 5) for 4 weeks. Eight patients had enterocutaneous fistulae.

    Materials and Methods
    Activity of the disease was assessed at the beginning and after the 4 weeks by the use of Crohn’s Disease Activity Index (CDAI). Anthropometric, biochemical and clinical variables were also recorded. Medical treatment was left unchanged for the enteral nutrition treatment duration.

    Results
    • A clinical improvement was seen in 69% as per CDAI score.
    • In addition, 4 out of 8 patients saw a 50% reduction in secretion of the fistulae after 4 weeks.
    • One patient saw a complete closure of the fistula.
    • Overall the feed was well tolerated with only one patient experiencing nausea and one experiencing diarrhoea as the recorded side effects.
    • Reduction was seen in CRP and ESR levels.


    Conclusion
    This study shows that a polymeric diet rich in TGF-β could play a significant part in improving nutritional outcomes for adult patients with mild to moderately active Crohn’s disease.
    Average: 2.8 (6 votes)

    Towards Optimised Management of Cow’s Milk Protein Allergy

    Medical Speciality

    This symposium took place during the 2018 meeting of the European Academy of Allergy and Clinical Immunology (EAACI). Focussing on the fundamental issues of suboptimal management of patients with cow’s milk protein allergy (CMPA), the speakers discussed key themes for optimising management.

    Prof Madrazo-de la Garza evaluated the challenges of diagnosis and management of CMPA in infants. Nonspecific symptoms, indicative of other conditions, mean that CPMA is often misdiagnosed as lactose intolerance, a rare condition in infants. Increased awareness of CMPA symptoms and a clear distinction from lactose intolerance may facilitate earlier, accurate diagnosis and implementation of appropriate dietary interventions.

    Dr Nutten followed by exploring variability in the composition of commercialised extensively hydrolysed formulas (eHF) intended for the management of CMPA and the associated potential clinical impact. Large variations in peptide profiles and residual allergenicity reflect a lack of definition for eHF composition. Although the clinical trials required to confirm the efficacy of eHF by demonstrating tolerance in >90% of infants with CMPA are performed, composition analyses for characterisation, quality control, and reproducibility are crucial for ensuring safe and suitable products throughout the product lifecycle.

    Prof O’Mahony concluded the meeting by focussing on the importance of the gut microbiome in food allergy. The establishment of a stable gut microbial community closely tracks host growth and immune development. Delayed or altered establishment leads to microbiome immaturity, which has been associated with an increased risk of food allergies. Nutritional strategies, such as the use of eHF containing lactose, to support microbiome development complement existing CMPA treatment.1


    Read the full symposium notes here.





    References:
    1. Armando J et al. EMJ Allergy and Immunol 2018; 3(1): 50–59.







    IMPORTANT NOTICE: Mothers should be encouraged to continue breastfeeding even when their infants have cows’ milk protein allergy. This usually requires qualified dietary counselling to completely exclude all sources of cows’ milk protein from the mothers’ diet. If a decision to use a special formula intended for infants is taken, it is important to give instructions on correct preparation methods, emphasising that unboiled water, unsterilised bottles or incorrect dilution can all lead to illness. Formula for special medical purposes intended for infants must be used under medical supervision.
    Average: 4.7 (3 votes)
    José Armando
    Professor Madrazo-de la Garza
    Dr. Sophie Nutten
    Professor Liam O’Mahony