Actively Recruiting
Infant Microbiota Restoration With Maternal Microbes to Compare Maternal Bacteria and Probiotics in C-Section Born Infants
Led by University of Helsinki · Updated on 2025-10-08
100
Participants Needed
2
Research Sites
N/A
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
This research aims to evaluate different bacterial products to restore natural gut microbiota in infants born by C-section. The study compares whether bacteria derived from the mother are more effective than commercially available probiotic strains in making the gut microbiota of C-section born infants resemble that of vaginally born infants. It addresses the concern that C-section birth disrupts normal microbiota, which may increase the risk of chronic diseases. Infants will be randomly assigned to receive one of several bacterial mixtures orally once daily for either one or four weeks. These include probiotic strains currently on the market, bacteria isolated from the infant's own mother in varying mixtures, bacteria from unrelated donors, or a placebo treatment without bacteria. The study is conducted at the University of Helsinki and uses a double-blind design. Participants will provide fecal, urine, and saliva samples at multiple time points up to one year to analyze microbiota composition and fecal metabolites. Researchers will monitor changes at 1, 5, 11, 26, and 52 weeks. The trial includes healthy mothers with singleton pregnancies planning to breastfeed and healthy infants born by planned C-section. The observation period extends through the infant's first year of life.
CONDITIONS
Brief 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 planning to breastfeed or feed breastmilk by bottle to the infant
- Infants expected to be healthy and not requiring BCG vaccination
You will not qualify if you...
- Living more than a 2-hour drive from Meilahti, Helsinki, Finland
- Mothers not planning to breastfeed or feed breastmilk by bottle
- Mothers diagnosed with gestational diabetes or pre-eclampsia
- Mothers receiving antibiotics during pregnancy or delivery
- Premature infants born before week 37 of pregnancy
- Infants born by urgent or emergency cesarean section
- Infants receiving antibiotics during the first week of life
- Infants with disease, congenital anomaly, or Apgar score less than 9 at 5 minutes
- Infants receiving BCG vaccination
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 52 weeks
Participants receive microbiota restoration treatments including probiotics, maternal bacteria, or placebo to study effects on infant gut microbiota.
Visits at 1 week, 5 weeks, 11 weeks, 26 weeks, and 52 weeks
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
M
Marjo Metsäranta, MD, PhD
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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