EnterostomyMUC-FIRENCT03469609
Mucous Fistula Refeeding Reduces the Time From Enterostomy Closure to Full Enteral Feeds ("MUC-FIRE" Trial)
A study testing mucous fistula refeeding in people with Enterostomy, run by University of Leipzig at 17 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Enterostomy
- What is being tested?
- mucous fistula refeeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 17 sitesin 3 countries
- Study dates
- 18 Jun 2018to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants < 366 days,
- Ileostomy / Jejunostomy,
- double loop enterostomies and split enterostomies (with mucous fistula)
- 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
Who cannot join
- resection of ileocecal valve,
- colostomy,
- small bowel atresia,
- multiple ostomies (more than just an enterostomy and a mucous fistula),
- chromosomal abnormalities (if known at the time of randomization),
- Hirschsprung's disease,
- participation in another drug-intervention study
- Intestinal perforation due to a hemodynamic heart defect
Trial locations and contacts
17 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
17 sites in 3 countries
Germany13 sites, 10 recruiting
- Recruiting
University Hospital Augsburg, Clinic for Pediatric Surgery
Augsburg, 86156
Tobias Schuster, Dr. med.
- Terminated
Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Kinderchirurgie
Dresden, Saxony, 01304
- Terminated
Zentrum der Chirurgie, Klinik für Kinderchirurgie
Frankfurt am Main, Hesse, 60590
- Not yet recruiting
Hamburg [University Hospital Hamburg Eppendorf/UKE & Altonaer Kinderkrankenhaus/AKK]
Hamburg, 20246
Konrad Reinshagen, Prof. Dr.
- Recruiting
Auf der Bult, Kinder- und Jugendkrankenhaus, Kinderchirurgie und Kinderurologie
Hanover, Lower Saxony, 30173
Barbara Ludwikowski, PD Dr.
- Recruiting
Hannover Medical School, Clinic for Pediatric Surgery
Hanover, Lower Saxony, 30625
Julia Brendel, PD Dr. med.
- Recruiting
University of Leipzig
Leipzig, Saxony, 04103
Martin Lacher, Prof. Dr., muc-fire-leipzig@medizin.uni-leipzig.de
- Withdrawn
Universitätsmedizin Mainz, Klinik und Poliklinik für Kinderchirurgie
Mainz, Rhineland-Palatinate, 55131
- Recruiting
University Hospital Marburg, Clinic for Pediatric Surgery
Marburg, 35043
Guido Seitz, Prof. Dr.
- Recruiting
Städtisches Klinikum München GmbH/ Klinikum Schwabing
München, Bavaria, 80804
Stuart Hosie, Prof. Dr.
- Recruiting
Munich Clinic Harlaching
München, 81545
Marcus Krüger, Prof. Dr. med.
- Recruiting
Universitätsklinik für Kinder- und Jugendmedizin Tübingen
Tübingen, Baden-Wurttemberg, 72076
Christian Poets, Prof. Dr.
- Recruiting
Marien Hospital Witten, Ruhr-University Bochum, Department of Pediatric Surgery
Witten, North Rhine-Westphalia, 58452
Jochen Hubertus, Prof. Dr.
Austria2 sites, 2 recruiting
- Recruiting
Universitätsklinik für Kinder- und Jugendchirurgie
Graz, 8036
Holger Till, Univ. Prof.
- Recruiting
Universitätsklinik für Kinder- und Jugendheilkunde
Vienna, 1090
Christoph Binder, Dr.
Netherlands2 sites, 2 recruiting
- Recruiting
Amsterdam University Medical Centers
Amsterdam, 1000 GG
Ernest van Heurn, Prof. Dr.
- Recruiting
Erasmus University Medical Center Rotterdam
Rotterdam, 3015 CE
H.R. (Hester) Langeveld-Benders, Dr.
About this study
Official title: 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.
Read the 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.
- Conditions
- Enterostomy
- Being tested
- mucous fistula refeeding
- Keywords
- infants, necrotizing enterocolitis (NEC), focal intestinal perforation (FIP), enterostomy creation, bowel reanastomosis, enteral feeding, caloric intake, parenteral nutrition, complication rate, reduction of hospital expenses, length of hospital stay, refeeding
- Medical subject headings
- Enterocolitis, Necrotizing, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mucous fistula refeedingOther
Transfer of infants' own stool
| Study group | Role | What they receive |
|---|---|---|
| Perioperative mucous fistula refeeding | Experimental | Perioperative mucous fistula refeeding between enterostomy creation and enterostomy closure Receives: Other: mucous fistula refeeding |
| No mucous fistula refeeding | No intervention | No perioperative mucous fistula refeeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to full enteral feeds (hours)
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.
- 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.
- The nutrition aim is 90 kcal/kg/24h for born mature infants, mother's gestation week at birth at least 37+0.
Measured: week 4 to week 12 daily
Secondary outcomes (15)
Time to first bowel movement
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
Measured: Week 4 to week 12 daily
Thriving
Measurement of body weight
Measured: Week 1 to week 12 daily; follow-up (month 3, 6, 12)
Z-Score (standard deviation score)
Measurement of weight [weight for age, World Health Organization (WHO)]
Measured: Week 1 to week 12 daily, follow-up (month 3, 6, 12)
Number of days of postoperative total parenteral nutrition (TPN)
Calculation of days of postoperative TPN starts on the day of operation and ends on the day of full enteral nutrition
Measured: Week 2 to week 12 daily, follow-up (month 3, 6, 12)
Laboratory parameter indicating cholestasis
Measurement of conjugated Bilirubin (µmol/l)
Measured: Week 1 to week 12 daily, follow-up (month 3)
Assessment of adverse events (AEs)
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.
Measured: Week 1 to week 12 daily, follow-up (month 3, 6, 12)
Assessment of serious adverse events (SAEs)
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.
Measured: Week 1 to week 12 daily, follow-up (month 3, 6, 12)
Postoperative weight gain (g/d)
Weight gain during the subsequent 5 days after reaching the primary endpoint following enterostomy closure
Measured: week 4 to week 12
Central venous line (CVL)
duration (days) and number of CVL infections (definition of infection: Neo-Kiss Guidelines)
Measured: Week 1 to week 12
hospitalisation
Length of hospital stay (days)
Measured: week 1 to week 12
jump in caliber
Estimated ratio of the diameter of the two bowel loops which are anastomosed.
Measured: week 5
Sodium resorption
Sodium in Urine (mmol/l)
Measured: Week 1 to week 12 daily, follow-up (month 3)
Status of liver enzymes
Gamma-Glutamyltransferase (GGT) , Alanine-Aminotransferase (ALT) , Aspartate-Aminotransferase (AST) (µkat/l)
Measured: Week 1 to week 12 daily, follow-up (month 3)
Laboratory parameters
Haemoglobin (g/dl)
Measured: Week 1 to week 12 daily, follow-up (month 3)
Time to full volume intake per day (in hours)
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).
- 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.
- The volume aim is 120 ml/kg/24h for born mature infants, mother's gestation week at birth at least 37+0.
Measured: week 4 to week 12 daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start18 Jun 2018
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EnterostomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, open-label, randomized, parallel group, controlled trial
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation, Hannover Medical School
- Responsible party
- Principal investigator, Martin Lacher, University of Leipzig
- Investigators
- Omid Madadi-Sanjani, PD Dr. med., Principal investigator, University Medical Center Hamburg-Eppendorf (UKE), Department of Pediatric SurgeryMartin Lacher, Prof. Dr. med., Principal investigator, University of Leipzig, Department of Pediatric Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469609
- Sponsor's protocol ID
- MUC-FIRE
- Acronym
- MUC-FIRE
- Status last verified
- Aug 2026
- First submitted
- 28 Feb 2018
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grosshennig A, Wiesner S, Hellfritsch J, Thome U, Knupfer M, Peter C, Metzelder M, Binder C, Wanz U, Flucher C, Brands BO, Mollweide A, Ludwikowski B, Koluch A, Scherer S, Gille C, Theilen TM, Rochwalsky U, Karpinski C, Schulze A, Schuster T, Weber F, Seitz G, Gesche J, Nissen M, Jager M, Koch A, Ure B, Madadi-Sanjani O, Lacher M. MUC-FIRE: Study protocol for a randomized multicenter open-label controlled trial to show that MUCous FIstula REfeeding reduces the time from enterostomy closure to full enteral feeds. Contemp Clin Trials Commun. 2023 Feb 20;32:101096. doi: 10.1016/j.conctc.2023.101096. eCollection 2023 Apr.
PubMed 36875554
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03469609
- Acronym / sponsor ID
- MUC-FIRE / MUC-FIRE
- Conditions
- Enterostomy
- Keywords
- infants, necrotizing enterocolitis (NEC), focal intestinal perforation (FIP), enterostomy creation, bowel reanastomosis, enteral feeding, caloric intake, parenteral nutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Collaborators
- German Research Foundation, Hannover Medical School
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 19 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter, open-label, randomized, parallel group, controlled trial
| Arm | Type | Receives |
|---|---|---|
| Perioperative mucous fistula refeeding | Experimental | Other: mucous fistula refeedingPerioperative mucous fistula refeeding between enterostomy creation and enterostomy closure |
| No mucous fistula refeeding | No intervention | –No perioperative mucous fistula refeeding |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants < 366 days,
- Ileostomy / Jejunostomy,
- double loop enterostomies and split enterostomies (with mucous fistula)
- 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
Key exclusion criteria (8 listed)
- resection of ileocecal valve,
- colostomy,
- small bowel atresia,
- multiple ostomies (more than just an enterostomy and a mucous fistula),
- chromosomal abnormalities (if known at the time of randomization),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mucous fistula refeedingTransfer of infants' own stool | Other | Perioperative mucous fistula refeeding |
Primary outcome
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.
15 secondary outcomes
Time to first bowel movement
Time frame: Week 4 to week 12 daily
Thriving
Time frame: 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)
Number of days of postoperative total parenteral nutrition (TPN)
Time frame: 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)
Assessment of adverse events (AEs)
Time frame: 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)
Postoperative weight gain (g/d)
Time frame: week 4 to week 12
Central venous line (CVL)
Time frame: Week 1 to week 12
hospitalisation
Time frame: week 1 to week 12
jump in caliber
Time frame: week 5
Sodium resorption
Time frame: 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)
Laboratory parameters
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Derived from this study: PubMed 36875554Grosshennig A, Wiesner S, Hellfritsch J, Thome U, Knupfer M, Peter C, Metzelder M, Binder C, Wanz U, Flucher C, Brands BO, Mollweide A, Ludwikowski B, Koluch A, Scherer S, Gille C, Theilen TM, Rochwalsky U, Karpinski C, Schulze A, Schuster T, Weber F, Seitz G, Gesche J, Nissen M, Jager M, Koch A, Ure B, Madadi-Sanjani O, Lacher M. MUC-FIRE: Study protocol for a randomized multicenter open-label controlled trial to show that MUCous FIstula REfeeding reduces the time from enterostomy closure to full enteral feeds. Contemp Clin Trials Commun. 2023 Feb 20;32:101096. doi: 10.1016/j.conctc.2023.101096. eCollection 2023 Apr.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Omid Madadi-Sanjani, PD Dr. med. principal investigator
University Medical Center Hamburg-Eppendorf (UKE), Department of Pediatric Surgery
Martin Lacher, Prof. Dr. med. principal investigator
University of Leipzig, Department of Pediatric Surgery
17 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mucous fistula refeeding in people with Enterostomy, run by University of Leipzig at 17 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Germany, Austria, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Lacher, Prof. Dr. med. (+49-341-97 ext. 26400, muc-fire-leipzig@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to full enteral feeds (hours) (time frame: week 4 to week 12 daily). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03469609, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.