Restore a newborn's gut microbiota using the mother's microbes.
Infant Microbiota Restoration With Maternal Microbes
This will test whether giving C-section newborns bacteria from their own mother or commercial probiotics helps their gut microbiota become more like babies born vaginally.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | N/A to 50 Years |
| Sex | All |
| Sponsor | University of Helsinki Academic / other |
| Locations | 2 sites (Helsinki and 1 other locations) |
| Trial ID | NCT07212361 on ClinicalTrials.gov |
What this trial studies
The trial compares selective maternal-derived bacterial products, a commercial probiotic, and placebo to restore gut microbiota in infants born by cesarean section. Infants receive an oral bacterial product once daily for either one or four weeks and parents collect fecal, urine, and saliva samples for microbiome and safety analysis. Treated C-section infants are compared to untreated C-section infants and to vaginally born infants to determine whether the treatments make the microbiota resemble that of vaginally born babies. The project is led by the Faculty of Medicine at the University of Helsinki and conducted at Helsinki University Hospital.
Who should consider this trial
Good fit: Ideal candidates are healthy full-term infants born by planned cesarean whose mothers are healthy, speak Finnish or Swedish, plan to provide breastmilk, and live within about a two-hour drive of Meilahti, Helsinki.
Not a fit: Infants born prematurely, those who receive antibiotics in the first week, those with major congenital anomalies or low Apgar scores, or infants of mothers with pregnancy complications are unlikely to qualify or benefit.
Why it matters
Potential benefit: If successful, this could restore a more natural infant microbiome and potentially reduce long-term health risks associated with cesarean-related microbiota disturbances.
How similar studies have performed: Previous small studies using maternal fecal microbiota transplant have shown promising restoration of C-section infant microbiota, but selective maternal-derived products are a newer, less-tested approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Helsinki and 1 other locations
- Helsinki University Hospital — Helsinki, Finland (Recruiting)
- University of Helsinki — Helsinki, Finland (Recruiting)
Study contacts
- Study coordinator: Katri E Korpela, PhD
- Email: katri.korpela@helsinki.fi
- Phone: +358504486369
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.