NCT07212361 Infant Microbiota Restoration With Maternal Microbes
| NCT ID | NCT07212361 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Helsinki |
| Condition | Infant, Newborn |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-07-17 |
| Primary Completion | 2035-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-07-17 with a primary completion date of 2035-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07212361 clinical trial?
This trial is open to participants of all sexes, up to 50 Years, studying Infant, Newborn. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07212361 currently recruiting?
Yes, NCT07212361 is actively recruiting participants. Contact the research team at katri.korpela@helsinki.fi for enrollment information.
Where is the NCT07212361 trial being conducted?
This trial is being conducted at Helsinki, Finland, Helsinki, Finland.
Who is sponsoring the NCT07212361 clinical trial?
NCT07212361 is sponsored by University of Helsinki. The trial plans to enroll 100 participants.