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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.

Keywords: Bifidobacterium breve M-16V; Hydrolysed formula; ITT, intention-to-treat; Infant growth; PP, per-protocol; RMMM, repeated-measures mixed model; Randomised controlled trials; SCORAD, SCORing Atopic Dermatitis; Synbiotics; scGOS/lcFOS, short-chain galacto-oligosaccharides/long-chain fructo-oligosaccharides.

Research Insights

SupplementHealth OutcomeEffect TypeEffect Size
Bifidobacterium breveAchieved Adequate Infant GrowthBeneficial
Large
Bifidobacterium breveIncreased Adverse EventsNeutral
Large
Bifidobacterium breve Bb-03Achieved Adequate Infant GrowthBeneficial
Large
Bifidobacterium breve Bb-03Increased Faecal Bifidobacteria LevelsBeneficial
Moderate
Bifidobacterium breve Bb-03Reduced Percentage of Clostridium lituseburense and Clostridium histolyticumBeneficial
Moderate
Bifidobacterium breve BBr60Achieved Adequate Infant GrowthBeneficial
Large
Bifidobacterium breve BBr60Increased Adverse EventsNeutral
Large
Bifidobacterium breve BBr60Increased Faecal Bifidobacteria LevelsBeneficial
Moderate
Bifidobacterium breve BBr60Reduced Faecal Clostridium PopulationBeneficial
Moderate
Bifidobacterium breve Bbr8Achieved Adequate Infant GrowthBeneficial
Large
Bifidobacterium breve Bbr8Increased Fecal Bifidobacteria LevelsBeneficial
Moderate
Bifidobacterium breve Bbr8Reduced Percentage of Clostridium lituseburense and Clostridium histolyticumBeneficial
Moderate
Bifidobacterium breve IDCC 4401Achieved Adequate Infant GrowthBeneficial
Large
Bifidobacterium breve IDCC 4401Increased Faecal Bifidobacteria LevelsBeneficial
Moderate
Bifidobacterium breve IDCC 4401Reduced Fecal Clostridium LevelsBeneficial
Moderate
Bifidobacterium breve M-16VAchieved Adequate Infant GrowthBeneficial
Large
Bifidobacterium breve M-16VIncreased Adverse EventsNeutral
Large
Bifidobacterium breve M-16VIncreased Fecal Bifidobacteria LevelsBeneficial
Moderate
Bifidobacterium breve M-16VNo Significant Changes in Blood ParametersNeutral
Small
Bifidobacterium breve M-16VReduced Percentage of Clostridium lituseburense and Clostridium histolyticumBeneficial
Moderate
Bifidobacterium breve Rosell-70Achieved Adequate Infant GrowthBeneficial
Large
Bifidobacterium breve Rosell-70Increased Faecal Bifidobacteria LevelsBeneficial
Moderate
Bifidobacterium breve Rosell-70Reduced Faecal Clostridium PopulationBeneficial
Moderate
Bifidobacterium breve VPro 52Improved Growth MetricsBeneficial
Moderate
Bifidobacterium breve VPro 52Increased Faecal Bifidobacteria LevelsBeneficial
Moderate
Bifidobacterium breve VPro 52Similar Frequency of Adverse EventsNeutral
Moderate

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