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

Study Timeline

• Study First Submitted: 2025-06-13
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-07
• Study First Posted: 2025-07-08
• Study Start: 2025-07-15
• Last Update Submitted: 2025-07-16
• Last Update Posted: 2025-07-20
• Primary Completion: 2027-12-31
• Study Completion: 2028-07-01

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

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