Actively Recruiting
Infant Microbiota Restoration With Maternal Microbes
Led by University of Helsinki · Updated on 2025-10-08
100
Participants Needed
2
Research Sites
545 weeks
Total Duration
On this page
Sponsors
U
University of Helsinki
Lead Sponsor
H
Helsinki University Central Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 maternally derived strains of bacteria perform better than commercially available probiotic strains in restoring the gut microbiota of C-section born infants? Researchers will compare the gut microbiota of treated infants to that of untreated C-section born infants and untreated vaginally born infants to see if the bacterial treatments cause the microbiota to resemble that of vaginally born infants. Participants will be given a bacterial product orally once daily for either one or four weeks and be asked to collect faecal, urine and saliva samples.
CONDITIONS
Official Title
Infant Microbiota Restoration With Maternal Microbes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Helsinki University Hospital
Helsinki, Finland
Actively Recruiting
2
University of Helsinki
Helsinki, Finland
Actively Recruiting
Research Team
K
Katri E Korpela, PhD
CONTACT
M
Marjo Metsäranta, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
6
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