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C-Section babies get Mom's gut bugs in new trial

NCT ID NCT07212361

Knowledge-focused Sponsor: University of Helsinki Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests if giving C-section babies bacteria from their mother can help restore their gut health to be more like babies born vaginally. About 100 healthy infants will receive a daily oral bacterial product for one or four weeks. Researchers will compare their gut bacteria to untreated C-section and vaginally born babies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Dec 2035

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 50 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

disease Dysbiosis human disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cesarean delivery affecting newborn Cesarean section Delivery, obstetric FECES Gastrointestinal microbiota Gut dysbiosis Gut microbiota HUMANS Infant, newborn Microbiology Microbiota Microbiota, cesarean section, probiotics, dysbiosis Neonate Pregnancy Vaginal delivery

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Helsinki University Hospital

    RECRUITING

    Helsinki, Finland

  • University of Helsinki

    RECRUITING

    Helsinki, Finland

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