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Can a Food-Based tube formula reshape a Child's gut bacteria?

NCT ID NCT07816536

Knowledge-focused Sponsor: Establishment for Children and Adolescents in the Nantes Region 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are observing children aged 1 to 16 who receive all their nutrition through a gastrostomy tube. The study checks how the mix of gut bacteria changes after the children switch to Compleat Paediatric Nature Mix, a formula made from food-derived ingredients. Over six months, the team also tracks digestion, bowel habits, sleep quality, and feeding rate. This small observational study aims to understand the formula's effects, not to prove a treatment benefit.

What this could mean

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

Active substance
a food-based enteral nutrition formula (Compleat Paediatric Nature Mix)
What this could lead to
If the food-based formula shifts gut bacteria in helpful ways, it could guide better nutrition choices for children who rely on tube feeding.
What could go wrong
This is a tiny observational study of 8 children at one center, so it cannot prove the formula causes any change. Results may not apply to other children or formulas.

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 8 people

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

Started

Mar 2026

Expected to finish

May 2027

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

Children receiving exclusive enteral nutrition via gastrostomy and followed in a pediatric healthcare center.

Ages

1 year to 16 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Children aged 1 to 16 years * Exclusive enteral nutrition * Followed as part of routine care at the participating pediatric center * Legal guardians and caregivers able to understand French * Covered by the French social security system or equivalent * Documented non-opposition from legal representatives and, when possible, from the child Exclusion Criteria: * Oral feeding or non-exclusive enteral nutrition * Use of oral nutritional supplements * Requirement for hypercaloric (\>1.2 kcal/mL) or hypocaloric (\<1 kcal/mL) enteral formulas * Acute clinical decompensation within one month prior to inclusion * Acute viral or bacterial gastroenteritis within one month prior to inclusion * Antibiotic or probiotic use within three months prior to inclusion

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Conditions

The condition(s) this trial relates to.

eating disorder rumination disorder

As listed by the trial registrant

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

Enteral nutrition dependence Feeding and eating disorders of childhood

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

  • ESEAN - APF France Handicap

    RECRUITING

    Nantes, France

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