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Probiotic for Infants

Not Applicable
Not yet recruiting
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
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Total abundance of BifidobacteriaAt 3 months of age

Abundance of Bifidobacteria in infant fecal samples by quantitative PCR

Secondary Outcome Measures
NameTimeMethod
Infant fecal pHBirth (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 compositionBirth (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 consistency4 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, Denmark
Andreas Munk Petersen, MD, PhD, DMSc
Contact
+45 38 62 61 99
andreas.munk.petersen@regionh.dk

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