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New formula aims to fix gut health in C-Section babies

NCT ID NCT07162025

Knowledge-focused Sponsor: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is working on a special infant formula for babies born by C-section, who often miss out on beneficial bacteria from the birth canal. Researchers will first collect breast milk and baby stool samples from mothers who gave birth vaginally to find helpful probiotics and healthy fats. Then they will create an improved formula and test it in a lab model. The goal is to support better gut colonization and reduce health issues linked to C-section births.

What this could mean

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

Active substance
infant formula enriched with probiotics and physiological lipids
What this could lead to
If successful, this could lead to a specialized infant formula that helps C-section babies develop a healthier gut, potentially reducing long-term health risks.
What could go wrong
This is a very early, small study (40 participants) focused on formula development and lab testing, not on proving health benefits in babies. The formula may not show clear advantages in future trials.

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.

Participants

About 40 people

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

Started

Sep 2025

Expected to finish

Sep 2028

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.

Who is studied

Breastfeeding mothers and their babies under 6 months old

Ages

18 years and older

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: * Breastfeeding mothers: Aged 18 years and older Breastfeeding for less than 6 months Not having taken probiotics in the 6 months prior to sampling Not having taken antibiotics in the 6 months prior to sampling No chronic medical conditions Not undergoing chronic treatment No history of gestational diabetes Body mass index (BMI) below 25 at the start of pregnancy Having given their consent to participate in the study and to the collection of their baby's stool samples Not deprived of liberty or placed under guardianship \- Babies: Aged less than 6 months Born vaginally Born at term or at least 37 weeks of pregnancy Exclusively breastfed Not having received intrapartum antibiotic treatment Having no known medical conditions Not receiving any medical supplements other than conventional vitamins Whose mothers meet the inclusion criteria detailed above Exclusion Criteria: Breastfeeding mothers: * Under the age of 18 * Breastfeeding for 6 months or more * Having been on antibiotic therapy in the 6 months prior to sampling * Having taken probiotics in the 6 months prior to sampling * Having a chronic illness * Undergoing chronic treatment * Who have developed gestational diabetes * Who have a BMI greater than 25 at the start of pregnancy * Who have given their consent to participate in the study (breast milk collection) but not to the collection of their baby's stool samples * Who are deprived of their liberty or under guardianship. Babies: * Aged over 6 months * Born by caesarean section * Born before 37 weeks of pregnancy * Not exclusively breastfed * Having undergone intrapartum antibiotic treatment * Taking medical supplements other than conventional vitamins * Presenting with any type of pathology * Whose mothers meet the non-inclusion criteria detailed above * Receiving medical supplementation other than conventional vitamins

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Conditions

The condition(s) this trial relates to.

Breast Feeding

As listed by the trial registrant

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

Breastfeeding mothers of legal age Their babies under 6 months old born vaginally

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

  • INRAE

    RECRUITING

    Jouy-en-Josas, 78350, France