Restoring the Beneficial Effects of Enterohepatic Bile Salt Signalling by Chyme Reinfusion in Pat… (NCT02990195) | Clinical Trial Compass
CompletedPhase 2
Restoring the Beneficial Effects of Enterohepatic Bile Salt Signalling by Chyme Reinfusion in Patients With a Double Enterostomy
France, Netherlands13 participantsStarted 2016-12-01
Plain-language summary
Multicentre prospective human experimental study to determine the effect of chyme reinfusion in patients with a double enterostomy on plasma levels of Fibroblast Growth Factor (FGF19)
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age equal or above 18 years old
* Temporary double enterostomy treated by chyme reinfusion as a routine primary care
* Downstream bowel of at least 25 cm of healthy small bowel, accessible by a stoma, and suitable for chyme reinfusion and ileal biopsy
* In case of enterocutaneous fistula, diagnosis of fistula origin and localization confirmed by additional medical imaging (computerized tomography/fistulography)
* Written informed consent.
Exclusion Criteria:
* Patients with a mental disability
* Pregnancy or lactation
* Hepatocellular carcinoma
* Blood coagulation disorders
* Shock of any cause
* Patients subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty
What they're measuring
1
Effect of chyme reinfusion in patients with a double enterostomy on plasma levels of FGF19