RecruitingNot Applicable

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

Austria, Germany120 participantsStarted 2018-06-18

Plain-language 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.

Who can participate

Age range12 Months

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Time to full enteral feeds (hours)

Timeframe: week 4 to week 12 daily

Trial details

NCT IDNCT03469609

SponsorUniversity of Leipzig

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Martin Lacher, Prof. Dr. med.

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

View on ClinicalTrials.gov More Enterostomy trials