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

April 27, 2026 updated by: Martin Lacher, University of Leipzig

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Enterostomies in children may be created for different reasons. During the presence of an enterostomy the regular stool transfer is interrupted as the distal part of the bowel (the part following the enterostomy) does not participate in the circulation of stool. Therefore it does not contribute to the resorption of enteral contents. As a consequence these children need additional parenteral nutrition. Due to the negative side-effects of parenteral nutrition all patients should return to enteral nutrition as soon as possible. Consequently, many pediatric surgical centers worldwide routinely perform mucous fistula refeeding (MFR) into the former unused bowel after enterostomy creation because case reports and retrospective analyses show low complication rates and faster postoperative weight gain. Several providers, however, shy away from this approach because to date there is still no high quality evidence for the benefit of this Treatment.The aim of this study is to assess the effects of mucous fistula refeeding in a randomized, prospective trial. We hypothesize that MFR between enterostomy creation and enterostomy closure reduces the time to full enteral feeds after enterostomy closure compared to the group without refilling. Moreover, the side effects of parenteral nutrition may be reduced and the postoperative hospital care of infants undergoing ostomy closure shortened.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Recruiting
        • Universitätsklinik für Kinder- und Jugendchirurgie
        • Contact:
          • Holger Till, Univ. Prof.
      • Vienna, Austria, 1090
        • Recruiting
        • Universitätsklinik für Kinder- und Jugendheilkunde
        • Contact:
          • Christoph Binder, Dr.
  • Germany
      • Augsburg, Germany, 86156
        • Recruiting
        • University Hospital Augsburg, Clinic for Pediatric Surgery
        • Contact:
          • Tobias Schuster, Dr. med.
      • Hamburg, Germany, 20246
        • Not yet recruiting
        • Hamburg [University Hospital Hamburg Eppendorf/UKE & Altonaer Kinderkrankenhaus/AKK]
        • Contact:
          • Konrad Reinshagen, Prof. Dr.
      • Marburg, Germany, 35043
        • Recruiting
        • University Hospital Marburg, Clinic for Pediatric Surgery
        • Contact:
          • Guido Seitz, Prof. Dr.
      • München, Germany, 81545
        • Recruiting
        • Munich Clinic Harlaching
        • Contact:
          • Marcus Krüger, Prof. Dr. med.
    • Baden-Wurttemberg
      • Tübingen, Baden-Wurttemberg, Germany, 72076
        • Recruiting
        • Universitätsklinik für Kinder- und Jugendmedizin Tübingen
        • Contact:
          • Christian Poets, Prof. Dr.
    • Bavaria
      • München, Bavaria, Germany, 80804
        • Recruiting
        • Städtisches Klinikum München GmbH/ Klinikum Schwabing
        • Contact:
          • Stuart Hosie, Prof. Dr.
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60590
        • Terminated
        • Zentrum der Chirurgie, Klinik für Kinderchirurgie
    • Lower Saxony
      • Hanover, Lower Saxony, Germany, 30173
        • Recruiting
        • Auf der Bult, Kinder- und Jugendkrankenhaus, Kinderchirurgie und Kinderurologie
        • Contact:
          • Barbara Ludwikowski, PD Dr.
      • Hanover, Lower Saxony, Germany, 30625
        • Recruiting
        • Hannover Medical School, Clinic for Pediatric Surgery
        • Contact:
          • Julia Brendel, PD Dr. med.
    • North Rhine-Westphalia
      • Witten, North Rhine-Westphalia, Germany, 58452
        • Recruiting
        • Marien Hospital Witten, Ruhr-University Bochum, Department of Pediatric Surgery
        • Contact:
          • Jochen Hubertus, Prof. Dr.
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, 55131
        • Withdrawn
        • Universitätsmedizin Mainz, Klinik und Poliklinik für Kinderchirurgie
    • Saxony
      • Dresden, Saxony, Germany, 01304
        • Terminated
        • Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Kinderchirurgie
      • Leipzig, Saxony, Germany, 04103
  • Netherlands
      • Amsterdam, Netherlands, 1000 GG
        • Recruiting
        • Amsterdam University Medical Centers
        • Contact:
          • Ernest van Heurn, Prof. Dr.
      • Rotterdam, Netherlands, 3015 CE
        • Recruiting
        • Erasmus University Medical Center Rotterdam
        • Contact:
          • H.R. (Hester) Langeveld-Benders, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Perioperative mucous fistula refeeding
Perioperative mucous fistula refeeding between enterostomy creation and enterostomy closure
Other: mucous fistula refeeding
Transfer of infants' own stool
No Intervention: No mucous fistula refeeding
No perioperative mucous fistula refeeding

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to full enteral feeds (hours)
Time Frame: 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.
week 4 to week 12 daily

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to first bowel movement
Time Frame: Week 4 to week 12 daily
Cleaning and changing of infants diapers will be performed according to a fixed schedule in order to uniformly document the time to first bowel movement
Week 4 to week 12 daily
Thriving
Time Frame: Week 1 to week 12 daily; follow-up (month 3, 6, 12)
Measurement of body weight
Week 1 to week 12 daily; follow-up (month 3, 6, 12)
Z-Score (standard deviation score)
Time Frame: Week 1 to week 12 daily, follow-up (month 3, 6, 12)
Measurement of weight [weight for age, World Health Organization (WHO)]
Week 1 to week 12 daily, follow-up (month 3, 6, 12)
Number of days of postoperative total parenteral nutrition (TPN)
Time Frame: Week 2 to week 12 daily, follow-up (month 3, 6, 12)
Calculation of days of postoperative TPN starts on the day of operation and ends on the day of full enteral nutrition
Week 2 to week 12 daily, follow-up (month 3, 6, 12)
Laboratory parameter indicating cholestasis
Time Frame: Week 1 to week 12 daily, follow-up (month 3)
Measurement of conjugated Bilirubin (µmol/l)
Week 1 to week 12 daily, follow-up (month 3)
Assessment of adverse events (AEs)
Time Frame: Week 1 to week 12 daily, follow-up (month 3, 6, 12)
Adverse events will be collected by the investigator either based on the information provided spontaneously by the parents of patient or evaluated by non-suggestive questions.
Week 1 to week 12 daily, follow-up (month 3, 6, 12)
Assessment of serious adverse events (SAEs)
Time Frame: Week 1 to week 12 daily, follow-up (month 3, 6, 12)
Adverse events will be collected by the investigator either based on the information provided spontaneously by the parents of patient or evaluated by non-suggestive questions.
Week 1 to week 12 daily, follow-up (month 3, 6, 12)
Postoperative weight gain (g/d)
Time Frame: week 4 to week 12
Weight gain during the subsequent 5 days after reaching the primary endpoint following enterostomy closure
week 4 to week 12
Central venous line (CVL)
Time Frame: Week 1 to week 12
duration (days) and number of CVL infections (definition of infection: Neo-Kiss Guidelines)
Week 1 to week 12
hospitalisation
Time Frame: week 1 to week 12
Length of hospital stay (days)
week 1 to week 12
jump in caliber
Time Frame: week 5
Estimated ratio of the diameter of the two bowel loops which are anastomosed.
week 5
Sodium resorption
Time Frame: Week 1 to week 12 daily, follow-up (month 3)
Sodium in Urine (mmol/l)
Week 1 to week 12 daily, follow-up (month 3)
Status of liver enzymes
Time Frame: Week 1 to week 12 daily, follow-up (month 3)
Gamma-Glutamyltransferase (GGT) , Alanine-Aminotransferase (ALT) , Aspartate-Aminotransferase (AST) (µkat/l)
Week 1 to week 12 daily, follow-up (month 3)
Laboratory parameters
Time Frame: Week 1 to week 12 daily, follow-up (month 3)
Haemoglobin (g/dl)
Week 1 to week 12 daily, follow-up (month 3)
Time to full volume intake per day (in hours)
Time Frame: week 4 to week 12 daily

Time to full age-dependent volume intake per day (defined as 150ml/kg/24h for premature infants and 120ml/kg/24h for mature born infants as well as corrected mature infants) (in hours).

  1. The volume aim is 150 ml/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 volume aim is 120 ml/kg/24h for born mature infants, mother's gestation week at birth at least 37+0.
week 4 to week 12 daily

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Leipzig

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
German Research Foundation
Hannover Medical School

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Omid Madadi-Sanjani, PD Dr. med., University Medical Center Hamburg-Eppendorf (UKE), Department of Pediatric Surgery
  • Principal Investigator: Martin Lacher, Prof. Dr. med., University of Leipzig, Department of Pediatric Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 18, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MUC-FIRE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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