Mucous fistula refeeding to speed up recovery after enterostomy closure
Official title: A Randomized Multicenter Open-label Controlled Trial to Show That Mucous Fistula Refeeding Reduces the Time From Enterostomy Closure to Full Enteral Feeds (MUCous FIstula REfeeding ("MUC-FIRE") Trial)
Run by University of Leipzig · NCT03469609 · Data updated 2026-11-12
This study is testing if a special feeding method can help infants recover faster after surgery to close their enterostomy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 12 Months |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | University of Leipzig Academic / other |
| Locations | 17 sites (Graz and 16 other locations) |
| Status | Recruiting |
| Started | June 18, 2018 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | August 17, 2026 |
| Trial ID | NCT03469609 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are infants under 366 days old who have undergone ileostomy or jejunostomy with a mucous fistula.
✕Probably not a fit
Patients who may not benefit from this study include those with colostomies, small bowel atresia, or other significant gastrointestinal abnormalities.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effectiveness of mucous fistula refeeding (MFR) in infants who have undergone enterostomy creation. By comparing MFR to standard care, the researchers seek to determine if MFR can reduce the time it takes for infants to achieve full enteral feeds after their enterostomy is closed. The study will involve a randomized, prospective design to gather high-quality evidence on the benefits of this approach, which may also help minimize the side effects associated with parenteral nutrition. The ultimate goal is to improve postoperative care and recovery times for these infants.
Why it matters
Potential benefit: If successful, this approach could significantly shorten the time to full enteral feeding for infants after enterostomy closure, improving their recovery and reducing reliance on parenteral nutrition.
How similar studies have gone: While there have been case reports and retrospective analyses suggesting benefits of mucous fistula refeeding, this study represents a novel, high-quality prospective evaluation of the approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Universitätsklinik für Kinder- und Jugendchirurgie
Graz, Austria Recruiting -
Universitätsklinik für Kinder- und Jugendheilkunde
Vienna, Austria Recruiting -
Universitätsklinik für Kinder- und Jugendmedizin Tübingen
Tübingen, Baden-Wurttemberg, Germany Recruiting -
Städtisches Klinikum München GmbH/ Klinikum Schwabing
München, Bavaria, Germany Recruiting -
Auf der Bult, Kinder- und Jugendkrankenhaus, Kinderchirurgie und Kinderurologie
Hanover, Lower Saxony, Germany Recruiting -
Hannover Medical School, Clinic for Pediatric Surgery
Hanover, Lower Saxony, Germany Recruiting
Show 11 more locations
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Marien Hospital Witten, Ruhr-University Bochum, Department of Pediatric Surgery
Witten, North Rhine-Westphalia, Germany Recruiting -
University of Leipzig
Leipzig, Saxony, Germany Recruiting -
University Hospital Augsburg, Clinic for Pediatric Surgery
Augsburg, Germany Recruiting -
University Hospital Marburg, Clinic for Pediatric Surgery
Marburg, Germany Recruiting -
Munich Clinic Harlaching
München, Germany Recruiting -
Amsterdam University Medical Centers
Amsterdam, Netherlands Recruiting -
Erasmus University Medical Center Rotterdam
Rotterdam, Netherlands Recruiting -
Zentrum der Chirurgie, Klinik für Kinderchirurgie
Frankfurt am Main, Hesse, Germany Terminated -
Universitätsmedizin Mainz, Klinik und Poliklinik für Kinderchirurgie
Mainz, Rhineland-Palatinate, Germany Withdrawn -
Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Kinderchirurgie
Dresden, Saxony, Germany Terminated -
Hamburg [University Hospital Hamburg Eppendorf/UKE & Altonaer Kinderkrankenhaus/AKK]
Hamburg, Germany Not yet recruiting
Study contacts
- Principal investigator: Omid Madadi-Sanjani, PD Dr. med. — University Medical Center Hamburg-Eppendorf (UKE), Department of Pediatric Surgery
- Study coordinator: Martin Lacher, Prof. Dr. med.
- Email: muc-fire-leipzig@medizin.uni-leipzig.de
- Phone: +49-341-97
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.