Abstract
The objective of the present study was to evaluate the growth and tolerance in healthy, term infants consuming a synbiotic formula with daily weight gain as the primary outcome. In a randomised, controlled, double-blind, multicentre, intervention study infants were assigned to an extensively hydrolysed formula containing a specific combination of Bifidobacterium breve M-16V and a prebiotic mixture (short-chain galacto-oligosaccharides and long-chain fructo-oligosaccharides in a 9:1 ratio; scGOS/lcFOS; synbiotic group), or the same formula without this synbiotic concept for 13 weeks (control group). Anthropometry, formula intake, tolerance, stool characteristics, blood parameters, faecal microbiota and metabolic faecal profile were assessed. Medically confirmed adverse events were recorded throughout the study. Equivalence in daily weight gain was demonstrated for the intention-to-treat (ITT) population (n 211). In the per-protocol (PP) population (n 102), the 90% CI of the difference in daily weight gain slightly crossed the lower equivalence margin. During the intervention period, the mean weight-for-age and length-for-age values were close to the median of the WHO growth standards in both groups, indicating adequate growth. The number of adverse events was not different between both groups. No relevant differences were observed in blood parameters indicative for liver and renal function. At 13 weeks, an increased percentage of faecal bifidobacteria (60 v. 48%) and a reduced percentage of Clostridium lituseburense/C. histolyticum (0·2 v. 2·6%) were observed in the synbiotic group (n 19) compared with the control group (n 27). In conclusion, this study demonstrates that an extensively hydrolysed formula with B. breve M-16V and the prebiotic mixture scGOS/lcFOS (9:1) supports an adequate infant growth.
Highlights
The objective of the present study was to evaluate the growth and tolerance in healthy, term infants consuming a synbiotic formula with daily weight gain as the primary outcome
The large number of screening failures was due to the fact that most of the infants were not exclusively formula fed at the time of screening
A substantial amount of 109 infants was excluded from the PP population due to protocol violations or dropping-out from the study
Summary
The objective of the present study was to evaluate the growth and tolerance in healthy, term infants consuming a synbiotic formula with daily weight gain as the primary outcome. A specific mixture of short-chain galacto-oligosaccharides and long-chain fructooligosaccharides (scGOS/lcFOS; 9:1 ratio) supplemented to infant formula was found to modulate the microbiota of infants towards a composition with more bifidobacteria and less potential pathogenic bacteria such as clostridia-related species[11,12,13] It reduced the number of infectious episodes in healthy and at-risk infants[14,15] and due to its modulatory effect on the immune system, reduced the risk of atopic dermatitis and some allergic manifestations during infancy and childhood in infants with a high risk of developing allergy[11,14,16]. First, the nutritional safety and adequacy of the addition of such a new functional ingredient should be demonstrated following stringent evaluation[22,23,24]
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