Synbiotics‐supplemented amino acid‐based formula supports adequate growth in cow's milk allergic infants

Abstract

Background: Children with cow's milk allergy (CMA) are at risk for inadequate nutritional intake and growth. Dietary management of CMA, therefore, requires diets that are not only hypoallergenic but also support adequate growth in this population. This study assessed growth of CMA infants when using a new amino acid-based formula (AAF) with prebiotics and probiotics (synbiotics) and evaluated its safety in the intended population. Methods: In a prospective, randomized, double-blind controlled study, full-term infants with diagnosed CMA received either an AAF (control; n = 56) or AAF with synbiotics (oligofructose, long-chain inulin, acidic oligosaccharides, Bifidobacterium breve M-16V) (test; n = 54) for 16 wk. Primary outcome was growth, measured as weight, length and head circumference. Secondary outcomes included allergic symptoms and stool characteristics. Results: Average age (AESD) of infants at inclusion was 4.5 AE 2.4 months. Both formulas equally supported growth according to WHO 2006 growth charts and resulted in similar increases of weight, length and head circumference. At week 16, differences (90% CI) in Z-scores (test-control) were as follows: weight 0.147 (À0.10; 0.39, p = 0.32), length À0.299 (À0.69; 0.09, p = 0.21) and head circumference 0.152 (À0.15; 0.45, p = 0.40). Weight-for-age and length-for-age Z-scores were not significantly different between the test and control groups. Both formulas were well tolerated and reduced allergic symptoms; the number of adverse events was not different between the groups. Conclusions: This is the first study that shows that an AAF with a specific synbiotic blend, suitable for CMA infants, supports normal growth and growth similar to the AAF without synbiotics.This clinical trial is registered as NCT00664768.

A Specific Mixture of Fructo-Oligosaccharides and Bifidobacterium breve M-16V Facilitates Partial Non-Responsiveness to Whey Protein in Mice Orally Exposed to β-Lactoglobulin-Derived Peptides

“…Further, the use of synbiotic mixtures containing Bb M-16V was found effective in preventing CMA allergic symptoms (29, 30) as well as house dust mite-induced allergic asthma in mice (31). In a recent clinical trial with infant formulas, it was reported that children fed a formula containing fructo-oligosaccharides and Bb M-16V had an increased percentage bifidobacteria in their feces (32). Bb M-16V is suggested to enhance the homing process of naïve T cells to mesenteric lymph nodes (MLN), induce mucosal IgA production (33), and upregulate the TGF-β1 signaling (34), while they can partially modulate the TNF-α signaling in epithelial cells (35).…”

Review of Pro- and/or Prebiotics in Extensively Hydrolyzed or Amino Acid-Based Infant Formula for Food Allergy

“…Both formulas met hypoallergenicity criteria set by the American Academy of Pediatrics (AAP) [39]. Three studies included in this review found that AAF with synbiotics resulted in normal tolerance and either normal or increased growth in patients [31,34,40]. There were two cases of adverse gastrointestinal effects in this review; an increase in the incidence of diarrhea [34] and gastrointestinal intolerance due to heat-inactivated Lactobacillus GG [32].…”

“…However, the use of viable Lactobacillus GG in the same study did not have any adverse effects [32]. In a second study, diarrhea was reported in 4% of subjects in the control group and in 22% of subjects in the treatment group receiving AAF supplemented with Bifidobacterium breve and a prebiotic mixture of oligofructose, long-chain inulin, and acidic oligosaccharides [34].…”

“…One study found that Lactobacillus casei and Bifidobacterium lactis, when added to EHF, did not have any effect on hospital admissions [29]. The remaining two studies found that Bifidobacterium breve and a mixture of prebiotics resulted in a lower incidence of infection and antibiotic use [31,34].…”

“…Both studies found that synbiotic-supplemented AAF supported normal growth and both control and treatment groups experienced increases in weight, length, and head circumference, with no significant differences between the two groups [31,34].…”