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Baby poop refeeding: could it speed up recovery after bowel surgery?

NCT ID NCT03469609

Disease control Sponsor: University of Leipzig 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 18, 2026 · Updated 2 times

Summary

This study tests a procedure called mucous fistula refeeding in 120 infants who have a temporary bowel opening (enterostomy). The idea is to take the baby's own stool and put it back into the lower bowel to help it get ready to work again. The goal is to see if this helps babies reach full feeds faster after the bowel is reconnected, compared to standard care.

What this could mean

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

Active substance
infant's own stool (mucous fistula refeeding)
What this could lead to
If it works, this could help infants with bowel surgery reach full feeds faster, reducing hospital stays and need for IV nutrition.
What could go wrong
This is a small, early-stage trial with 120 infants. The approach is unusual and may not work for all babies, or could cause discomfort or infection.

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 120 people

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

Started

Jun 2018

Expected to finish

Dec 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.

Ages

Up to 12 months

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: 1. Infants \< 366 days, 2. Ileostomy / Jejunostomy, 3. double loop enterostomies and split enterostomies (with mucous fistula) 4. Signed written informed consent obtained by parents/legal guardians and willingness of parents/legal guardians to comply with treatment and follow-up procedures of their child Exclusion Criteria: 1. resection of ileocecal valve, 2. colostomy, 3. small bowel atresia, 4. multiple ostomies (more than just an enterostomy and a mucous fistula), 5. chromosomal abnormalities (if known at the time of randomization), 6. Hirschsprung's disease, 7. participation in another drug-intervention study 8. Intestinal perforation due to a hemodynamic heart defect

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Conditions

The condition(s) this trial relates to.

Hyperphagia necrotizing enterocolitis

As listed by the trial registrant

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

Enterostomy

How to take part

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

  1. The places running it

    14 sites in 3 countries. 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

  • Amsterdam University Medical Centers

    RECRUITING

    Amsterdam, 1000 GG, Netherlands

  • Auf der Bult, Kinder- und Jugendkrankenhaus, Kinderchirurgie und Kinderurologie

    RECRUITING

    Hanover, Lower Saxony, 30173, Germany

  • Erasmus University Medical Center Rotterdam

    RECRUITING

    Rotterdam, 3015 CE, Netherlands

  • Hamburg [University Hospital Hamburg Eppendorf/UKE & Altonaer Kinderkrankenhaus/AKK]

    NOT_YET_RECRUITING

    Hamburg, 20246, Germany

  • Hannover Medical School, Clinic for Pediatric Surgery

    RECRUITING

    Hanover, Lower Saxony, 30625, Germany

  • Marien Hospital Witten, Ruhr-University Bochum, Department of Pediatric Surgery

    RECRUITING

    Witten, North Rhine-Westphalia, 58452, Germany

  • Munich Clinic Harlaching

    RECRUITING

    München, 81545, Germany

  • Städtisches Klinikum München GmbH/ Klinikum Schwabing

    RECRUITING

    München, Bavaria, 80804, Germany

  • University Hospital Augsburg, Clinic for Pediatric Surgery

    RECRUITING

    Augsburg, 86156, Germany

  • University Hospital Marburg, Clinic for Pediatric Surgery

    RECRUITING

    Marburg, 35043, Germany

  • University of Leipzig

    RECRUITING

    Leipzig, Saxony, 04103, Germany

  • Universitätsklinik für Kinder- und Jugendchirurgie

    RECRUITING

    Graz, 8036, Austria

  • Universitätsklinik für Kinder- und Jugendheilkunde

    RECRUITING

    Vienna, 1090, Austria

  • Universitätsklinik für Kinder- und Jugendmedizin Tübingen

    RECRUITING

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Kinderchirurgie

    TERMINATED

    Dresden, Saxony, 01304, Germany

  • Universitätsmedizin Mainz, Klinik und Poliklinik für Kinderchirurgie

    WITHDRAWN

    Mainz, Rhineland-Palatinate, 55131, Germany

  • Zentrum der Chirurgie, Klinik für Kinderchirurgie

    TERMINATED

    Frankfurt am Main, Hesse, 60590, Germany

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