Investigation of the impact of Bi2muno (Bi2GOS), a novel galacto-oligosaccharide mixture, on the composition of the infant faecal microbiota

INTERVENTION: Bi2muno (Bi2GOS) 3 g versus Placebo (Maltodextrin 3 g) Determine the effect of Bi2muno feeding (3 g/day) on the bifidobacterial component of formula‐fed infants' faecal microbiota. A double‐blind, randomised, placebo‐controlled, parallel design 1‐month feeding study will be performed using exclusively milk‐fed infants aged 8 to 10 weeks, at inclusion. Faecal samples will be collected from soiled nappies of each individual on four separate occasions: 2 at baselines (i.e. prior to commencement of the trial) and 2 post‐feeding. The bifidobacterial component of the faecal microbiota will be examined for all samples, both quantitatively (using Fluorescence in situ Hybridization [FISH]) and qualitatively (using Denaturing Gradient Gel Electrophoresis [DGGE], a molecular profiling technique). Comparisons will be made between baseline and post‐feeding samples to identify changes in the bifidobacterial microbiota over time. Also, comparisons will be made between the two feeding groups to determine the effect of Bi2muno on bifidobacterial predominance and diversity. Updated 19/02/2014: the trial was stopped due to poor recruitment. CONDITION: Infant formula ; Nutritional, Metabolic, Endocrine PRIMARY OUTCOME: To determine the effect of Bi2muno (Bi2GOS) 1 dose of 3 g/day on the bifidobacterial components (numbers and species diversity of the specific bacterial group) of formula‐fed infants' faecal microbiota SECONDARY OUTCOME: Not provided at time of registration INCLUSION CRITERIA: 1. Signed consent form 2. Age at inclusion: 8‐10 weeks 3. Fully formula fed infants