Actively Recruiting

Phase Not Applicable
Age: 0 - 12Months
All Genders
NCT03469609

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

Led by University of Leipzig · Updated on 2026-05-01

120

Participants Needed

17

Research Sites

493 weeks

Total Duration

On this page

Sponsors

U

University of Leipzig

Lead Sponsor

G

German Research Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 0 - 12Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Infants younger than 366 days
  • Presence of ileostomy or jejunostomy
  • Double loop enterostomies and split enterostomies with mucous fistula
  • Signed informed consent from parents or legal guardians and willingness to comply with study procedures
Not Eligible

You will not qualify if you...

  • Resection of the ileocecal valve
  • Presence of colostomy
  • Small bowel atresia
  • More than two ostomies (enterostomy plus mucous fistula)
  • Known chromosomal abnormalities at the time of randomization
  • Hirschsprung's disease
  • Participation in another drug-intervention study
  • Intestinal perforation caused by a hemodynamic heart defect

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 17 locations

1

Universitätsklinik für Kinder- und Jugendchirurgie

Graz, Austria, 8036

Actively Recruiting

2

Universitätsklinik für Kinder- und Jugendheilkunde

Vienna, Austria, 1090

Actively Recruiting

3

Universitätsklinik für Kinder- und Jugendmedizin Tübingen

Tübingen, Baden-Wurttemberg, Germany, 72076

Actively Recruiting

4

Städtisches Klinikum München GmbH/ Klinikum Schwabing

München, Bavaria, Germany, 80804

Actively Recruiting

5

Zentrum der Chirurgie, Klinik für Kinderchirurgie

Frankfurt am Main, Hesse, Germany, 60590

Terminated

6

Auf der Bult, Kinder- und Jugendkrankenhaus, Kinderchirurgie und Kinderurologie

Hanover, Lower Saxony, Germany, 30173

Actively Recruiting

7

Hannover Medical School, Clinic for Pediatric Surgery

Hanover, Lower Saxony, Germany, 30625

Actively Recruiting

8

Marien Hospital Witten, Ruhr-University Bochum, Department of Pediatric Surgery

Witten, North Rhine-Westphalia, Germany, 58452

Actively Recruiting

9

Universitätsmedizin Mainz, Klinik und Poliklinik für Kinderchirurgie

Mainz, Rhineland-Palatinate, Germany, 55131

Withdrawn

10

Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Kinderchirurgie

Dresden, Saxony, Germany, 01304

Terminated

11

University of Leipzig

Leipzig, Saxony, Germany, 04103

Actively Recruiting

12

University Hospital Augsburg, Clinic for Pediatric Surgery

Augsburg, Germany, 86156

Actively Recruiting

13

Hamburg [University Hospital Hamburg Eppendorf/UKE & Altonaer Kinderkrankenhaus/AKK]

Hamburg, Germany, 20246

Not Yet Recruiting

14

University Hospital Marburg, Clinic for Pediatric Surgery

Marburg, Germany, 35043

Actively Recruiting

15

Munich Clinic Harlaching

München, Germany, 81545

Actively Recruiting

16

Amsterdam University Medical Centers

Amsterdam, Netherlands, 1000 GG

Actively Recruiting

17

Erasmus University Medical Center Rotterdam

Rotterdam, Netherlands, 3015 CE

Actively Recruiting

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Research Team

M

Martin Lacher, Prof. Dr. med.

CONTACT

O

Omid Madadi-Sanjani, PD Dr. med.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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