MedTrace Logo

Influence of Probiotics on Early Gut Microbial Colonization

NCT07608341 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-05-27

No results posted yet for this study

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.

Conditions

  • C-Section

Interventions

DIETARY_SUPPLEMENT

Probiotic drops

Probiotic+vitamin D3 drops

DIETARY_SUPPLEMENT

Placebo drops

Placebo+vitamin D3

Sponsors & Collaborators

  • Aurevia

    collaborator INDUSTRY

  • BioGaia AB

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
3 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2030-08-01
Completion
2030-08-01

Countries

  • Finland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07608341 on ClinicalTrials.gov