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

ConditionEnterostomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 12
SponsorUniversity of Leipzig

About this 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.

Eligibility criteria

Qualifiers

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

Disqualifiers

resection of ileocecal valve,

colostomy,

small bowel atresia,

multiple ostomies (more than just an enterostomy and a mucous fistula),

Trial design

Treatments tested in this trial

  • mucous fistula refeeding

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Leipzig

Lead sponsor

German Research Foundation

Collaborator

Hannover Medical School

Collaborator