Children with cow’s milk allergy tolerate hydrolyzed whey-protein formula

Children and infants with cow’s milk allergy tolerated an extensively hydrolyzed whey-protein formula, providing suitable nutrition and enabling normal growth curves, according to study findings.

The formula also met international criteria for hypoallergenicity, Lamia Dahdah, MD, experienced specialist with the allergy unit in the pediatric university department at Bambino Gesù Children’s Hospital in Rome, and colleagues wrote in the study, published in Pediatric Allergy and Immunology.

When infants and children have cow’s milk allergy (CMA) and breastfeeding is not possible, hypoallergenic formulas based on extensively hydrolyzed proteins or amino acid mixtures that also are tolerable and nutritious are the only safe option, according to the researchers.

For the study, the researchers used a nutritionally complete, powdered and extensively hydrolyzed whey-protein formula (eHWF) not derived from non-porcine enzymes that was newly designed for infants and children with CMA.

The eHWF also was supplemented with prebiotic short-chain galacto-oligosaccharides and long-chain fructo-oligosaccharides as well as arachidonic acid and docosahexaenoic acid.

Conducted between January 2013 and March 2016, the study involved 36 children with CMA (age range, birth to 3 years). Twenty-five children (19 boys; mean age, 61 weeks) had no major protocol deviations affecting their evaluability and formed the per-protocol population (PP).

During the challenge phase, which 29 children completed, the children participated in a double-blind, placebo-controlled food challenge (DBPCFC) with the eHWF comprising two separate hospital visits within a 1-week timeframe.

The researchers monitored the children for acute allergic reactions for 2 hours after the DBPCFC. Children with negative results then consumed the eHWF in an open challenge for one week after the DBPCFC.

Twenty-three children who participated in the optional follow-up continued to consume the eHWF for 16 weeks. The researchers weighed and measured each child and assessed their parent-reported gastrointestinal tolerability.

There were no allergic reactions among the 25 children in the PP during the DBPCFC or during the open challenge, nor did any of the nine children excluded from the PP analysis have any allergic reactions.

However, the researchers reported repeated severe eczema during the 16-week follow-up in a boy aged 32 months with high total IgE and negative specific IgE levels against cow’s milk protein. The eczema resolved after the eHWF was removed from the boy’s diet.

Also, weight and length gain followed normal growth curves established by WHO and within WHO ranges, the researchers found, establishing eHWF as a suitable nutritional option for dietary management of CMA in infants.

Most of the 94 adverse events that occurred in 26 of the children were mild, and only three adverse events in two subjects were possibly related to the eHWF, the researchers wrote. None of the adverse events were serious, the researchers continued.

During weeks 3 through 8 of the follow-up, stool consistency was predominantly softer compared with baseline, but returned to baseline levels by the end of the follow-up. Almost all other parent-reported GI symptoms during the follow-up were mild.

With 95% confidence, the researchers wrote, at least 90% of infants or children with confirmed CMA tolerated the eHWF, meeting international criteria for hypoallergenicity established by the American Academy of Pediatrics.

But despite these results, the researchers wrote, the one child who experienced a late moderate eczematous allergic reaction during follow-up indicates the need to closely monitor all infants and children who start a new formula.