Status:
RECRUITING
Infant Microbiota Restoration With Maternal Microbes
Lead Sponsor:
University of Helsinki
Collaborating Sponsors:
Helsinki University Central Hospital
Conditions:
Infant, Newborn
Gut -Microbiota
Eligibility:
All Genders
Up to 50 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to test the ability of different bacterial products in restoring natural gut microbiota in C-section born infants. The main question it aims to answer is: Do matern...
Detailed Description
The gut microbiota has long-term effects on host health especially in early life. Infants receive maternal faecal microbes during vaginal birth, which is prevented by C-section. C-section is associate...
Eligibility Criteria
Inclusion
- Healthy mother and healthy pregnancy
- Singleton pregnancy,
- Mothers who speak Finnish or Swedish
- Mothers who are planning to breastfeed or give breastmilk by bottle to the infant
- Infants who are expected to be healthy and who will not require BCG vaccination.
Exclusion
- Participants who lives further than a 2-hour drive from Meilahti, Helsinki, Finland
- Mothers who are not planning to breastfeed or feed breastmilk by bottle to the infant
- Mothers who are diagnosed with gestational diabetes, pre-eclampsia or who have been receiving antibiotics during the pregnancy or delivery
- Premature infants born before the pregnancy week 37
- Infants, who are born by urgent cesarean section or emergency cesarean section
- Infants, who receive antibiotics during the first week of life
- Infants, who are diagnosed with a disease, congenital anomaly or who receive less than 9 Apgar points at 5 minutes.
- Infants, who receive BCG-vaccine
Key Trial Info
Start Date :
July 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2035
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07212361
Start Date
July 17 2025
End Date
December 31 2035
Last Update
October 8 2025
Active Locations (2)
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1
Helsinki University Hospital
Helsinki, Finland
2
University of Helsinki
Helsinki, Finland