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

NCT03469609 · tracked via the Priya Life Science Germany tracker

Sponsor

University of Leipzig

Phase

Not applicable

Started

2018-06-18

Last updated

2026-08-17

Condition(s) studied

Enterostomy

Investigational drug(s) / intervention(s)

mucous fistula refeeding

mucous fistula refeeding: Transfer of infants' own stool

Study 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

Sex

ALL

Min age

—

Max age

12 Months

Healthy volunteers

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

Primary outcome measure(s)

Time to full enteral feeds (hours) — week 4 to week 12 daily
Time to full feeds (hours), defined as time to actual enteral intake of the age-dependent caloric requirements per day (defined as 90 or 120kcal/kg/24h) for at least 24 hours and a concomitant reduction of parenteral fluids to \<20ml/kg/24h. 1. The nutrition aim is 120 kcal/kg/24h for premature infants with a birth weight \< 1000g or premature infants with a birth weight ≥ 1000g and mother's gestation week at birth before 37+0. 2. The nutrition aim is 90 kcal/kg/24h for born mature infants, mother's gestation week at birth at least 37+0.

Trial sites (17)

Facility	City	Region	Status
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	Recruiting
Städtisches Klinikum München GmbH/ Klinikum Schwabing	München	Bavaria	Recruiting
Zentrum der Chirurgie, Klinik für Kinderchirurgie	Frankfurt am Main	Hesse	Terminated
Auf der Bult, Kinder- und Jugendkrankenhaus, Kinderchirurgie und Kinderurologie	Hanover	Lower Saxony	Recruiting
Hannover Medical School, Clinic for Pediatric Surgery	Hanover	Lower Saxony	Recruiting
Marien Hospital Witten, Ruhr-University Bochum, Department of Pediatric Surgery	Witten	North Rhine-Westphalia	Recruiting
Universitätsmedizin Mainz, Klinik und Poliklinik für Kinderchirurgie	Mainz	Rhineland-Palatinate	Withdrawn
Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Kinderchirurgie	Dresden	Saxony	Terminated
University of Leipzig	Leipzig	Saxony	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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03469609 on ClinicalTrials.gov ↗ ← All trials in Germany