NCT03469609 Mucous Fistula Refeeding Reduces the Time From Enterostomy Closure to Full Enteral Feeds ("MUC-FIRE" Trial)
| NCT ID | NCT03469609 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Leipzig |
| Condition | Enterostomy |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2018-06-18 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2018-06-18 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Omid Madadi-Sanjani, PD Dr. med.
PRINCIPAL INVESTIGATOR
University Medical Center Hamburg-Eppendorf (UKE), Department of Pediatric Surgery
Frequently Asked Questions
Who can join the NCT03469609 clinical trial?
This trial is open to participants of all sexes, up to 12 Months, studying Enterostomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03469609 currently recruiting?
Yes, NCT03469609 is actively recruiting participants. Contact the research team at muc-fire-leipzig@medizin.uni-leipzig.de for enrollment information.
Where is the NCT03469609 trial being conducted?
This trial is being conducted at Graz, Austria, Vienna, Austria, Tübingen, Germany, München, Germany and 11 additional locations.
Who is sponsoring the NCT03469609 clinical trial?
NCT03469609 is sponsored by University of Leipzig. The principal investigator is Omid Madadi-Sanjani, PD Dr. med. at University Medical Center Hamburg-Eppendorf (UKE), Department of Pediatric Surgery. The trial plans to enroll 120 participants.