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Probiotic drops aim to boost gut health in C-Section infants

NCT ID NCT07608341

Disease control Sponsor: BioGaia AB Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether daily probiotic drops plus vitamin D3 can improve early gut bacteria in healthy babies born by C-section. 150 infants will receive either probiotic or placebo drops for 8 weeks, with stool samples and questionnaires. Results will be compared to vaginally born babies. The goal is to see if probiotics can help C-section infants develop a healthier gut microbiome.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Probiotic drops with vitamin D3
What this could lead to
If it works, this could help C-section babies develop a healthier gut microbiome, potentially reducing future health risks.
What could go wrong
This is an early-stage trial with no phase, so results are uncertain. The study is small (150 infants) and may not apply to all C-section 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 150 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

0 to 3 days

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: Infant born by planned C-section or vaginal born infant Gestational age at birth ≥ 37±0 weeks to \<41 ±0 weeks Infant Apgar score 7-10, (5 minutes after birth) Intention to breastfeed the infant Parents/legal guardians are \>18 years Parents/legal guardians have readiness and the opportunity to fill out a study diary, questionnaires and agree to collect biological samples Parents/legal guardians with ability to understand and comply with the requirements of the study, as judged by the Investigator Parents/legal guardians are willing and able to give written informed consent for their and their infants participation in the study Exclusion Criteria: \>72 hours after birth when collecting the first faecal sample and given the first drops of study product Infants classified as small for gestational age (SGA), defined as birth weight \< -2 standard deviations (SD) for gestational age and sex according to national reference standards. Infants with birth of congenital malformations or anomalies Infants not able to feed adequately by oral means at the time of screening (i.e., requiring tube feeding) Infants requiring care in neonatal unit Disruption of amniotic membranes for \>24 hours Infants consuming probiotics, including in infant formula Mothers use of antibiotics during the last 14 days of pregnancy prior to delivery Participation in other clinical studies Any other disease, condition, or circumstance that, in the investigator's opinion, may compromise the participant's safety, adherence to the protocol, or the interpretation of study results

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As listed by the trial registrant

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

C-section

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

    Helsinki, Finland

  • Tampere University Hospital

    Tampere, Finland

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