New Formula for Milk-Allergic Infants Has Pre- and Probiotics

Ingrid Hein

October 27, 2020

A new baby formula enriched with pre- and probiotics for babies with milk allergy improves their gut microbiome compared with standard hypoallergenic formula, potentially helping them develop a healthier immune system, similar to the benefits of human breast milk.

"This is meant for infants that have a severe cow's milk allergy," Harm Wopereis, PhD, of Danone Nutricia Research, told Medscape Medical News. He went on to say that breastfeeding offers babies the best nutritional start in life. When babies are severely allergic to cow's milk the mother has to go on a severely restrictive diet, and if this does not resolve a baby's symptoms, this type of formula can be prescribed by healthcare professionals.

Offering a standard synthetic formula alleviates the mother's restrictive diet but eliminates the benefits of the rich microbiotic diversity of mother's milk from the infant's diet.

For the mother, "it's an emotional time," coinvestigator Jane Langford, PhD, Danone Specialized Nutrition, told Medscape. Not breastfeeding "brings a level of guilt in every mother who wants to do the best for her child." The mother may feel that guilt when first switching to baby formula, "but when the baby's symptoms are quickly resolved, they are generally happy with the outcome. "

Enriched with human milk oligosaccharides (oligofructose, inulin) and the probiotic Bifidobacterium breve M-16V, the new formula shows promise not only for enriching the microbiome but also for helping the milk-allergic baby build a healthy immune system.

"What we're seeing in this trial is that we have real potential for this to work on the immune system's resilience....

"We can now go beyond symptom resolution to support the gut and immune system. This is an exciting development," Langford said.

Richer Microbiome in Infants Fed New Formula

Researchers recruited 169 mothers with babies less than 13 months old who had lgE-mediated cow's milk allergy. The trial was double-blinded and randomized. Eighty babies in the placebo group received an amino acid–based formula, and 89 babies in the study group were given an amino acid–based formula containing "synbiotics" (combinations of pre- and probiotics), including two oligosaccharides to mimic the oligosaccharides naturally found in breast milk — oligofructose, and inulin — and B breve M-16V.

The baby's stool microbiota were laboratory tested at baseline, at 6 months, and at 12 months. Researchers performed 16S ribosomal RNA-gene sequencing, oligotyping of Bifidobacteriaum, and analyzed taxa abundances.

During the 12 months of the trial, the researchers observed the infants. "At 12 months, we saw that half of the infants developed tolerance [to cow's milk]." It is normal for babies to grow out of their milk allergy, Wopereis said. "This was not different between the two groups.

"The interesting thing was the difference in the number of infections," Wopereis explained. In babies who drank the enriched formula, "there was less incidence of infections and less use of antibiotics — and this was a recurring finding."

Among the babies in the study group, the abundance of Bifidobacterium was increased, and there was a decrease in the abundance of Lachnospiraceae spp. In the infant gut, the good bacteria were at levels closer to that of healthy breastfed infants, the researchers reported.

The researchers saw an increase in good bacteria and a decrease in less good bacteria. "These synbiotics develop a more promising environment to encourage the growth of good bacteria," Wopereis said. "We are looking forward to seeing the long-term benefits, how it affects the children later in life."

Phases of the Allergic March

"There are very distinct phases of how the gut microbiome develops in the infant," Talal Chatila, MD, Harvard Medical School, Boston, Massachusetts, pointed out in his presentation on regulatory T cells and the microbiota in food allergy. "The immediate period post delivery, the maternal microbiota in the milk, and another phase around weaning time — these shape the early microbiome."

Charila explained that there is a lot of potential to develop novel therapies for the different phases. His work on a microbiota therapy that acts via the regulatory T-cell pathway to suppress food allergy shows promise. "But many questions still need to be answered."

Chatila has a financial relationship with ParetoBio. Wopereis and Langford are funded by Danone Nutricia.

FAAM-EUROBAT 2020: Oral abstract session 2, abstract 5, presented October 17, 2020

Ingrid Hein is a freelance health and technology reporter based in Hudson, Quebec, Canada.

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