Clinical Trial

Influence of Probiotics on Early Gut Microbial Colonization

Study acronym: STORKIE
Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07608341
Lead Sponsor BioGaia AB
Collaborators: Aurevia
Conditions C-Section
Enrollment 150 participants
Start Date 2026-08-01
Primary Completion 2030-08-01 (estimated)
Study Completion 2030-08-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-27