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NOT YET RECRUITING
NCT07608341
NA

Influence of Probiotics on Early Gut Microbial Colonization

Sponsor: BioGaia AB

View on ClinicalTrials.gov

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

DIETARY_SUPPLEMENT

Probiotic drops

Probiotic+vitamin D3 drops

DIETARY_SUPPLEMENT

Placebo drops

Placebo+vitamin D3

Locations (2)

Helsinki University Hospital

Helsinki, Finland

Tampere University Hospital

Tampere, Finland