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

NCT03469609 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-08-17

No results posted yet for this 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.

Conditions

  • Enterostomy

Interventions

OTHER

mucous fistula refeeding

Transfer of infants' own stool

Sponsors & Collaborators

  • German Research Foundation

    collaborator OTHER

  • Hannover Medical School

    collaborator OTHER

  • University of Leipzig

    lead OTHER

Principal Investigators

  • Omid Madadi-Sanjani, PD Dr. med. · University Medical Center Hamburg-Eppendorf (UKE), Department of Pediatric Surgery

  • Martin Lacher, Prof. Dr. med. · University of Leipzig, Department of Pediatric Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-18
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Austria
  • Germany
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03469609 on ClinicalTrials.gov