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Influence of Probiotics on Early Gut Microbial Colonization
Sponsor: BioGaia AB
Summary
The goal of this clinical trial is to learn whether daily probiotic drops plus vitamin D3 can improve early gut microbiome colonization in healthy infants born by C-section. It will also assess safety and tolerability. An intervention with probiotics + vitamin D3 will be compared to placebo + vitamin D3 in a double-blind, randomized design, and include an open-label vaginal-born reference group. Participants will receive study drops daily for 8 weeks and provide stool samples at multiple time points and complete questionnaires/diaries. After the intervention period, there is an optional follow-up period for up to 3 years.
Official title: Influence of Probiotics on Early Gut Microbial Colonization, Safety and Tolerability in Infants Born by Caesarean Section
Key Details
Gender
All
Age Range
0 Days - 3 Days
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2026-08-01
Completion Date
2030-08-01
Last Updated
2026-05-27
Healthy Volunteers
Yes
Conditions
Interventions
Probiotic drops
Probiotic+vitamin D3 drops
Placebo drops
Placebo+vitamin D3
Locations (2)
Helsinki University Hospital
Helsinki, Finland
Tampere University Hospital
Tampere, Finland