RecruitingNot Applicable

Infant Microbiota Restoration With Maternal Microbes

Finland100 participantsStarted 2025-07-17

Plain-language 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.

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Microbiota composition, relative and absolute abundances

Timeframe: 1 week, 5 weeks, 11 weeks, 26 weeks and 52 weeks.

Fecal metabolite profiles

Timeframe: 1 week, 5 weeks, 11 weeks, 26 weeks and 52 weeks

Trial details

NCT IDNCT07212361

SponsorUniversity of Helsinki

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2035-12-31

Contact for this trial

Katri E Korpela, PhD

+358504486369 katri.korpela@helsinki.fi

View on ClinicalTrials.gov More Infant, Newborn trials