Mucous Fistula Refeeding Reduces the Time From Enterostomy Closure to Full Enteral Feeds ("MUC-FIRE" Trial)
Launched by UNIVERSITY OF LEIPZIG · Mar 16, 2018
Trial Information
Current as of May 27, 2025
Recruiting
Keywords
ClinConnect Summary
The MUC-FIRE trial is studying a new way to help babies and young children with a type of surgical opening in their intestines, called an enterostomy. This trial is looking at whether feeding a small amount of food through a related opening, known as a mucous fistula, can help these children start eating normally faster after their surgery to close the enterostomy. This method is compared to the standard care currently provided.
To participate in this study, eligible children include infants under one year old who have had specific types of intestinal surgeries, such as ileostomy or jejunostomy. Parents or legal guardians must be willing to provide consent and follow the treatment plan. If your child is accepted into the trial, they will receive close monitoring and support during the feeding process. This study aims to improve the recovery experience for families by potentially shortening the time it takes for their child to return to a regular diet after surgery.
Gender
ALL
Eligibility 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
About University Of Leipzig
The University of Leipzig is a renowned academic institution in Germany, recognized for its commitment to advancing medical research and education. With a strong emphasis on interdisciplinary collaboration, the university fosters innovative clinical trials that aim to enhance patient care and contribute to the understanding of various health conditions. Its research initiatives are supported by state-of-the-art facilities and a diverse team of experts, positioning the University of Leipzig as a leader in the field of clinical research and a vital contributor to the global medical community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Wien, , Austria
Rotterdam, , Netherlands
Leipzig, Sachsen, Germany
Tübingen, Baden Württemberg, Germany
Graz, , Austria
München, Bayern, Germany
Frankfurt, Hessen, Germany
Hannover, Niedersachsen, Germany
Hannover, Niedersachsen, Germany
Mainz, Rheinland Pfalz, Germany
Dresden, Sachsen, Germany
Augsburg, , Germany
Hamburg, , Germany
Marburg, , Germany
Amsterdam, , Netherlands
Witten, Nordrhein Westfalen, Germany
Patients applied
Trial Officials
Omid Madadi-Sanjani, Dr. med.
Principal Investigator
Hannover Medical School, Department of Pediatric Surgery
Martin Lacher, Prof. Dr.
Principal Investigator
University of Leipzig, Department of Pediatric Surgery
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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