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C-Section babies get gut health boost in new probiotic trial

NCT ID NCT07320287

Prevention Sponsor: Anabio R&D Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 14, 2026 · Updated 2 times

Summary

This study tests whether giving a daily probiotic supplement to 180 healthy full-term babies born by C-section can help them gain weight, reduce colic and spit-up, and improve their gut bacteria. The babies will receive either one of two probiotic blends or a placebo for the first 90 days of life. Researchers will track growth, digestive symptoms, and stool samples to see if the probiotics make a difference.

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 180 people

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

Started

Jan 2026

Expected to finish

Jan 2027

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 days to 1 day

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 term neonates delivered by cesarean section. * Infants were born at term, ranging from 38 to 40 weeks' gestation. * Birth weight appropriate for gestational age (AGA), defined as between the 10th and 90th percentiles for gestational age (≥P10 and ≤P90). * The infant's parent(s) or legal guardian(s) provide written informed consent and agree to comply with study procedures. Exclusion Criteria: For the neonate: * Multiple births (twins, triplets, etc.) * Birth weight outside the appropriate-for-gestational-age range: small for gestational age (SGA, \< P10) or large for gestational age (LGA, \> P90). * Major congenital abnormalities affecting the hematologic, hepatobiliary, cardiovascular, renal/urinary, or gastrointestinal systems; severe inborn errors of metabolism; or suspected primary immunodeficiency. * Prior exposure to systemic or enteral antibiotics (oral, IV, or IM) before the baseline assessment. * Known allergy or intolerance to any component of the investigational product. * Concurrent participation in another interventional clinical trial. * The investigators judge the neonate to be unsuitable for participation. * Parent(s) or legal guardian(s) who do not comply with study requirements or refuse to sign the informed consent. For the mother: * Mother diagnosed with a serious or unstable medical condition involving the hepatobiliary, renal/urinary, cardiovascular, respiratory, endocrine/metabolic, or psychiatric systems. * Mother who intends to use, or is prescribed, any other probiotic/prebiotic product for herself or the infant during the study period.

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Conditions

The condition(s) this trial relates to.

digestive system disorder Weight Loss

As listed by the trial registrant

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

Functional gastrointestinal disorders (fgids) Weight loss

How to take part

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

  1. The places running it

    1 site. 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

  • Hanoi Obstetrics and Gynecology Hospital

    RECRUITING

    Hanoi, Vietnam

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