Probiotic for Infants
- Conditions
- Healthy Infants
- Registration Number
- NCT07054216
- Lead Sponsor
- Hvidovre University Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 378
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Total abundance of Bifidobacteria At 3 months of age Abundance of Bifidobacteria in infant fecal samples by quantitative PCR
- Secondary Outcome Measures
Name Time Method Infant fecal pH Birth (first stool after meconium), 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, and 1 year Changes in Fecal pH measured in fecal water from fecal samples
Infant gut microbiome composition Birth (first stool after meconium), 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, and 1 year Changes in gut microbiome composition analyzed by metagenomics analysis of fecal stool samples (shotgun DNA sequencing)
Proportion of infants with hard or very hard stool consistency 4 months, 5 months, 6 months 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
Trial Locations
- Locations (1)
Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling
🇩🇰Hvidovre, Denmark
Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling🇩🇰Hvidovre, DenmarkAndreas Munk Petersen, MD, PhD, DMScContact+45 38 62 61 99andreas.munk.petersen@regionh.dk