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Hypoallergenicity of a whey-based, extensively hydrolysed infant formula prepared with non porcine enzymes

Cows' Milk Allergy

31/03/2021

Nowak-Wegrzyn A, Czerkies L, Kuslys M, Nutten S, Simons PJ, Collins B and Heine RG.
Allergy 2019 Mar 21. doi: 10.1111/all.13780. Letter to the editor. Epub ahead of print

Objective

To characterize the peptide profile of a whey-based, extensively hydrolysed formula (eHF) prepared with a non porcine enzyme blend, and to assess whether it meets the hypoallergenicity criteria of the American Academy of Pediatrics (AAP).

Background

In the majority of formula‐fed infants with cows’ milk allergy (CMA), an eHF is considered the first‐line choice of formula. The manufacturing process for eHF traditionally involves the use of porcine pancreatic enzymes for the protein hydrolysis. However, these may not be considered suitable for religious (e.g. halal or kosher diet) or cultural (e.g. strict vegetarian diet) reasons. The AAP defines an eHF to be “hypoallergenic” if at least 90% of infants with CMA tolerate it under double‐blind, placebo‐controlled conditions (DBPCFC).

Materials and Methods

The Test formula was a whey‐based eHF (Althéra^®, Nestlé Health Science, Vevey, Switzerland) prepared with a microbial and plant‐derived, non porcine enzyme blend.
The Control formula was a marketed whey‐based eHF manufactured using porcine pancreatic enzymes (Althéra®, Nestlé Health Science, Vevey, Switzerland).
Peptide molecular weight (MW) distribution, residual milk allergen content and β-lactoglobulin (BLG) in vitro allergenicity were tested.
Hypoallergenicity and safety were clinically assessed through double-blind placebo-controlled food challenges (DBPCFC).
79 infants and children with CMA were enrolled and underwent the DBPCFC with both formulas in randomised order.
Hypoallergenicity was accepted if the exact 96.5% lower bound for the proportion of subjects without allergic reactions was at least 90% for the modified intention-to-treat (mITT) and per-protocol (PP) analysis populations.
If a subject successfully passed both DBPCFC sessions, a 1‐week open challenge with the Test formula was performed.

Results

Minor differences in the MW distribution were observed. No caseins, no intact milk proteins and only trace amounts of BLG were identified and in vitro tests did not demonstrate any residual BLG allergenicity.
Ten subjects were excluded due to inconclusive DBPCFC (<100 ml consumed).
The mITT analysis was performed based on 69 subjects (mean age 3.2 ± 2.22 years).
In the mITT cohort, 66/67 subjects (98.5%; lower bound 92.5%) tolerated the Test formula, while 67/69 (97.1%; lower bound 90.5%) tolerated the Control formula.
For the PP analysis, three patients were excluded due to protocol deviations.
Of the remaining 66 subjects (mean age 3.3 ± 2.21 years), 65 (98.5%, lower bound 92.4%) tolerated the Test formula, and 64 (97.0%, lower bound 90.1%) tolerated the Control formula.
Sixty‐five subjects completed the open‐label home challenge with Test formula.
There were no significant adverse clinical reactions.

Conclusion

Althéra^® prepared with non porcine enzymes was tolerated by at least 90% of children with CMA and meets the AAP hypoallergenicity criteria. Minor differences between Test and Control formulas regarding the MW distribution of peptides and residual BLG content did not translate into differences in clinical or in vitro allergenicity.

These findings confirm the hypoallergenicity and suitability of Althéra^® prepared with non porcine enzymes for the dietary management of CMA in infants and young children.

IMPORTANT NOTICE: Mothers should be encouraged to continue breastfeeding even when their infants have CMA. This usually requires qualified dietary counselling to completely exclude all sources of cows’ milk protein from the mother’s 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. © 2019 Nestlé. All rights reserved. Unless otherwise noted, all trademarks are owned by Société des Produits Nestlé SA. Study Summary prepared by Nestlé Health Science.

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.

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