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New treatment option for Enterostomy
Official title Mucous Fistula Refeeding Reduces the Time From Enterostomy Closure to Full Enteral Feeds ("MUC-FIRE" Trial)
ClinicalTrials.gov ID: NCT03469609
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 12
You may be able to join 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...
You likely can't join 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,
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Graz, Austria
- Vienna, Austria
- Tübingen, Baden-Wurttemberg, Germany
- München, Bavaria, Germany
- Frankfurt am Main, Hesse, Germany
- Hanover, Lower Saxony, Germany
- Witten, North Rhine-Westphalia, Germany
- Mainz, Rhineland-Palatinate, Germany
- Dresden, Saxony, Germany
- Leipzig, Saxony, Germany
- Augsburg, Germany
- Hamburg, Germany
- Marburg, Germany
- München, Germany
- Amsterdam, Netherlands
- Rotterdam, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 12 months. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Graz, Austria; Vienna, Austria; Tübingen, Baden-Wurttemberg, Germany; München, Bavaria, Germany; Frankfurt am Main, Hesse, Germany; Hanover, Lower Saxony, Germany and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.