Influence of Probiotics on Early Gut Microbial Colonization
Starting soon · Not applicable · Has a placebo group
Conditions studied: C-Section
In brief
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.
Key facts
- Study ID
- NCT07608341
- Run by
- BioGaia AB
- People needed
- 150
- Starts
- 2026-08-01
- Expected to finish
- 2030-08-01
- Last updated by the study team
- 2026-05-27
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Infant born by planned C-section or vaginal born infant
- Gestational age at birth ≥ 37±0 weeks to <41 ±0 weeks
- Infant Apgar score 7-10, (5 minutes after birth)
- Intention to breastfeed the infant
- Parents/legal guardians are >18 years
- Parents/legal guardians have readiness and the opportunity to fill out a study diary, questionnaires and agree to collect biological samples
- Parents/legal guardians with ability to understand and comply with the requirements of the study, as judged by the Investigator
- Parents/legal guardians are willing and able to give written informed consent for their and their infants participation in the study
You may not qualify if…
- >72 hours after birth when collecting the first faecal sample and given the first drops of study product
- Infants classified as small for gestational age (SGA), defined as birth weight < -2 standard deviations (SD) for gestational age and sex according to national reference standards.
- Infants with birth of congenital malformations or anomalies
- Infants not able to feed adequately by oral means at the time of screening (i.e., requiring tube feeding)
- Infants requiring care in neonatal unit
- Disruption of amniotic membranes for >24 hours
- Infants consuming probiotics, including in infant formula
- Mothers use of antibiotics during the last 14 days of pregnancy prior to delivery
- Participation in other clinical studies
- Any other disease, condition, or circumstance that, in the investigator's opinion, may compromise the participant's safety, adherence to the protocol, or the interpretation of study results
Where it is running
- Helsinki University Hospital — Helsinki, Finland
- Tampere University Hospital — Tampere, Finland
Full record on ClinicalTrials.gov
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