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Influence of Probiotics on Early Gut Microbial Colonization

Study acronym: STORKIE
StatusNot Yet Recruiting
PhaseNot applicable
SponsorBioGaia AB
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
BioGaia AB
8 trials monitored
See 1 trial at risk
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
(from sponsor)		 C-Section
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov