Influence of Probiotics on Early Gut Microbial Colonization

ConditionC-Section
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-3
SponsorBioGaia AB

About this trial

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.

Eligibility criteria

Qualifiers

None

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Probiotic drops
  • Placebo drops

Treatment groups

150 Participants
are divided into 3 treatment groups

Sponsors and collaborators

BioGaia AB

Lead sponsor

Aurevia

Collaborator