The BABIES II study is a single-center, randomized, double-blinded, placebo-controlled study in newborns with an 8½ months intervention period from 14 days of age to 9 months of age followed by a 3-months short-term follow-up period until 1 year of age and a possible long-term follow-up until 18 years of age. The study will evaluate the effect of supplementation with a probiotic strain on different health outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
378
Hvidovre Hospital
Hvidovre, Region Sjælland, Denmark
RECRUITINGCenter for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling
Hvidovre, Denmark
NOT_YET_RECRUITINGTotal abundance of Bifidobacteria
Abundance of Bifidobacteria in infant fecal samples by quantitative PCR
Time frame: At 3 months of age
Infant fecal pH
Changes in Fecal pH measured in fecal water from fecal samples
Time frame: Birth (first stool after meconium), 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, and 1 year
Infant gut microbiome composition
Changes in gut microbiome composition analyzed by metagenomics analysis of fecal stool samples (shotgun DNA sequencing)
Time frame: Birth (first stool after meconium), 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, and 1 year
Proportion of infants with hard or very hard stool consistency
The proportion of infants with episodes 'hard' and/or 'very hard' stool consistency assessed as the difference in numbers of infants who experience 'hard' and /or 'very hard' stool consistency during weaning (from first introduction of solid food) between the two groups
Time frame: 4 months, 5 months, 6 months
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