Mucous fistula refeeding to speed up recovery after enterostomy closure
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)
This study is testing if a special feeding method can help infants recover faster after surgery to close their enterostomy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | N/A to 12 Months |
| Sex | All |
| Sponsor | University of Leipzig Academic / other |
| Locations | 17 sites (Graz and 16 other locations) |
| Trial ID | NCT03469609 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are infants under 366 days old who have undergone ileostomy or jejunostomy with a mucous fistula.
Not a fit: Patients who may not benefit from this study include those with colostomies, small bowel atresia, or other significant gastrointestinal abnormalities.
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 performed: 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.
Eligibility criteria
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 this trial is running
Graz and 16 other locations
- 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)
- Zentrum der Chirurgie, Klinik für Kinderchirurgie — Frankfurt am Main, Hesse, Germany (Terminated)
- 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)
- Marien Hospital Witten, Ruhr-University Bochum, Department of Pediatric Surgery — Witten, North Rhine-Westphalia, Germany (Recruiting)
- 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)
- University of Leipzig — Leipzig, Saxony, Germany (Recruiting)
- University Hospital Augsburg, Clinic for Pediatric Surgery — Augsburg, Germany (Recruiting)
- Hamburg [University Hospital Hamburg Eppendorf/UKE & Altonaer Kinderkrankenhaus/AKK] — Hamburg, Germany (Not_yet_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)
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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.