NCT03469609

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
3 countries

17 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Jun 2018Dec 2027

First Submitted

Initial submission to the registry

February 28, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 19, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

June 18, 2018

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

9.5 years

First QC Date

February 28, 2018

Last Update Submit

April 27, 2026

Conditions

Enterostomy

Keywords

infantsnecrotizing enterocolitis (NEC)focal intestinal perforation (FIP)enterostomy creationbowel reanastomosisenteral feedingcaloric intakeparenteral nutritioncomplication ratereduction of hospital expenseslength of hospital stayrefeeding

Outcome Measures

Primary Outcomes (1)

  • 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. 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 Outcomes (15)

  • Time to first bowel movement

    Week 4 to week 12 daily

  • Thriving

    Week 1 to week 12 daily; follow-up (month 3, 6, 12)

  • Z-Score (standard deviation score)

    Week 1 to week 12 daily, follow-up (month 3, 6, 12)

  • Number of days of postoperative total parenteral nutrition (TPN)

    Week 2 to week 12 daily, follow-up (month 3, 6, 12)

  • Laboratory parameter indicating cholestasis

    Week 1 to week 12 daily, follow-up (month 3)

  • +10 more secondary outcomes

Study Arms (2)

Perioperative mucous fistula refeeding

EXPERIMENTAL

Perioperative mucous fistula refeeding between enterostomy creation and enterostomy closure

Other: mucous fistula refeeding

No mucous fistula refeeding

NO INTERVENTION

No perioperative mucous fistula refeeding

Interventions

mucous fistula refeedingOTHER

Transfer of infants' own stool

Perioperative mucous fistula refeeding

Eligibility Criteria

AgeUp to 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Universitätsklinik für Kinder- und Jugendchirurgie

Graz, 8036, Austria

RECRUITING

Universitätsklinik für Kinder- und Jugendheilkunde

Vienna, 1090, Austria

RECRUITING

Universitätsklinik für Kinder- und Jugendmedizin Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

Städtisches Klinikum München GmbH/ Klinikum Schwabing

München, Bavaria, 80804, Germany

RECRUITING

Zentrum der Chirurgie, Klinik für Kinderchirurgie

Frankfurt am Main, Hesse, 60590, Germany

TERMINATED

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

Hanover, Lower Saxony, 30173, Germany

RECRUITING

Hannover Medical School, Clinic for Pediatric Surgery

Hanover, Lower Saxony, 30625, Germany

RECRUITING

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

Witten, North Rhine-Westphalia, 58452, Germany

RECRUITING

Universitätsmedizin Mainz, Klinik und Poliklinik für Kinderchirurgie

Mainz, Rhineland-Palatinate, 55131, Germany

WITHDRAWN

Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Kinderchirurgie

Dresden, Saxony, 01304, Germany

TERMINATED

University of Leipzig

Leipzig, Saxony, 04103, Germany

RECRUITING

University Hospital Augsburg, Clinic for Pediatric Surgery

Augsburg, 86156, Germany

RECRUITING

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

Hamburg, 20246, Germany

NOT YET RECRUITING

University Hospital Marburg, Clinic for Pediatric Surgery

Marburg, 35043, Germany

RECRUITING

Munich Clinic Harlaching

München, 81545, Germany

RECRUITING

Amsterdam University Medical Centers

Amsterdam, 1000 GG, Netherlands

RECRUITING

Erasmus University Medical Center Rotterdam

Rotterdam, 3015 CE, Netherlands

RECRUITING

Related Publications (1)

  • 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.

    PMID: 36875554DERIVED

MeSH Terms

Conditions

Enterocolitis, NecrotizingHyperphagia

Condition Hierarchy (Ancestors)

EnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Lacher, Prof. Dr. med.

CONTACT

+49-341-97muc-fire-leipzig@medizin.uni-leipzig.de

Omid Madadi-Sanjani, PD Dr. med.

CONTACT

+49-176O.Madadi-Sanjani@uke.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Multicenter, open-label, randomized, parallel group, controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

February 28, 2018

First Posted

March 19, 2018

Study Start

June 18, 2018

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

NL(2)DE(13)AU(2)