Restoring the Beneficial Effects of Enterohepatic Bile Salt Signalling by Chyme Reinfusion in Patients With a Double Enterostomy

Rennes University Hospital13 enrolled

Overview

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)

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Double Enterostomy

Interventions

Chyme reinfusionOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

CHU de Rennes

Rennes, France

Clinique Saint Yves

Rennes, France

Maastricht University, Research Laboratories at the Department of General Surgery

Maastricht, Netherlands

Outcomes

Primary Outcomes

Effect of chyme reinfusion in patients with a double enterostomy on plasma levels of FGF19

Time frame: Week 7

Secondary Outcomes

Effect of chyme reinfusion in patients with a double enterostomy on plasma bile salt levels

Measurement of bile salt

Time frame: Week 7

Assessment of 7-alpha-hydroxy-4-cholesten-3-one (C4) plasma levels

Time frame: Week 7

Assessment of bile salt composition in plasma

Time frame: Week 7

Assessment of microbiotic profiling

Time frame: Week 7

Assessment of citrulline plasma levels

Time frame: Week 7

Assessment of intestinal-fatty acid binding protein (I-FABP) plasma levels

Time frame: Week 7

Assessment of smooth muscle specific (SM) 22 plasma levels

Time frame: Week 7

Effect of chyme reinfusion in patients with a double enterostomy on liver function

Time frame: Week 7

Assessment of lipopolysaccharide binding protein (LBP) plasma levels

Time frame: Week 7

Assessment of plasma levels of inflammatory cytokines interleukin-6 (IL-6)

Time frame: Week 7

Data from ClinicalTrials.gov

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