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Mucous Fistula Refeeding Reduces the Time From Enterostomy Closure to Full Enteral Feeds ("MUC-FIRE" Trial)

RecruitingNAAges any - 12 MonthsAllUniversity of Leipzig
NCT03469609 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The primary objective of this study is to demonstrate that mucous fistula refeeding between enterostomy creation and enterostomy closure reduces the time to full enteral feeds after enterostomy closure compared to standard of care.

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📋 Eligibility rules (as published)
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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What it tests

  • mucous fistula refeeding
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Where

17 sites
Universitätsklinik für Kinder- und Jugendchirurgie
Graz, Austria
Universitätsklinik für Kinder- und Jugendheilkunde
Vienna, Austria
Universitätsklinik für Kinder- und Jugendmedizin Tübingen
Tübingen, Germany
Städtisches Klinikum München GmbH/ Klinikum Schwabing
München, Germany
Zentrum der Chirurgie, Klinik für Kinderchirurgie
Frankfurt am Main, Germany
Auf der Bult, Kinder- und Jugendkrankenhaus, Kinderchirurgie und Kinderurologie
Hanover, Germany
Hannover Medical School, Clinic for Pediatric Surgery
Hanover, Germany
Marien Hospital Witten, Ruhr-University Bochum, Department of Pediatric Surgery
Witten, Germany

…and 9 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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