Clinical trial NCT02990195: Restoring the Beneficial Effects of Enterohepatic Bile Salt Signalling by Chyme Reinfusion in Patients With a Double Enterostomy
Official title: Restoring the Beneficial Effects of Enterohepatic Bile Salt Signalling by Chyme Reinfusion in Patients With a Double Enterostomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Double Enterostomy
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: Maastricht University Medical Center
First posted: 2016-12-13
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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)

Detailed description: Patients supported by chyme reinfusion will be followed for 3 days pre chyme reinfusion and for 7 weeks during chyme reinfusion. Three days prior chyme reinfusion, baseline characteristics will be determined, an ileal biopsy, blood, chyme and urine will be collected. Furthermore, blood, chyme, faeces and urine will be collected at the first day of chime reinfusion. These materials will be collected again at week 1, 3, 5 and 7 weeks after initiation of chyme reinfusion. A second ileal biopsy will be performed at week 3.

Eligibility criteria: 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

Primary outcomes:
measure: Effect of chyme reinfusion in patients with a double enterostomy on plasma levels of FGF19
timeFrame: Week 7
Secondary outcomes:
measure: Effect of chyme reinfusion in patients with a double enterostomy on plasma bile salt levels
timeFrame: Week 7
measure: Assessment of 7-alpha-hydroxy-4-cholesten-3-one (C4) plasma levels
timeFrame: Week 7
measure: Assessment of bile salt composition in plasma
timeFrame: Week 7
measure: Assessment of microbiotic profiling
timeFrame: Week 7
measure: Assessment of citrulline plasma levels
timeFrame: Week 7
measure: Assessment of intestinal-fatty acid binding protein (I-FABP) plasma levels
timeFrame: Week 7
measure: Assessment of smooth muscle specific (SM) 22 plasma levels
timeFrame: Week 7
measure: Effect of chyme reinfusion in patients with a double enterostomy on liver function
timeFrame: Week 7
measure: Assessment of lipopolysaccharide binding protein (LBP) plasma levels
timeFrame: Week 7
measure: Assessment of plasma levels of inflammatory cytokines interleukin-6 (IL-6)
timeFrame: Week 7
measure: Assessment of plasma levels of tumor necrosis factor-alpha (TNF-alpha)
timeFrame: Week 7
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de Rennes
city: Rennes
country: France
facility: Clinique Saint Yves
city: Maastricht
country: Netherlands
facility: Maastricht University, Research Laboratories at the Department of General Surgery
Study officials:
References:
citation: Koelfat KVK, Picot D, Chang X, Desille-Dugast M, van Eijk HM, van Kuijk SMJ, Lenicek M, Layec S, Carsin M, Dussaulx L, Seynhaeve E, Trivin F, Lacaze L, Thibault R, Schaap FG, Olde Damink SWM. Chyme Reinfusion Restores the Regulatory Bile Salt-FGF19 Axis in Patients With Intestinal Failure. Hepatology. 2021 Nov;74(5):2670-2683. doi: 10.1002/hep.32017. Epub 2021 Aug 26.