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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Double Enterostomy

Intervention / Treatment
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* Other: Chyme reinfusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Double enterostomy<br> | Other: Chyme reinfusion<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of chyme reinfusion in patients with a double enterostomy on plasma levels of FGF19 |  | Week 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of chyme reinfusion in patients with a double enterostomy on plasma bile salt levels | Measurement of bile salt | Week 7 | 
| Assessment of 7-alpha-hydroxy-4-cholesten-3-one (C4) plasma levels |  | Week 7 | 
| Assessment of bile salt composition in plasma |  | Week 7 | 
| Assessment of microbiotic profiling |  | Week 7 | 
| Assessment of citrulline plasma levels |  | Week 7 | 
| Assessment of intestinal-fatty acid binding protein (I-FABP) plasma levels |  | Week 7 | 
| Assessment of smooth muscle specific (SM) 22 plasma levels |  | Week 7 | 
| Effect of chyme reinfusion in patients with a double enterostomy on liver function |  | Week 7 | 
| Assessment of lipopolysaccharide binding protein (LBP) plasma levels |  | Week 7 | 
| Assessment of plasma levels of inflammatory cytokines interleukin-6 (IL-6) |  | Week 7 | 
| Assessment of plasma levels of tumor necrosis factor-alpha (TNF-alpha) |  | Week 7 |