Double Enterostomy
Conditions
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.
Interventions
OTHERChyme reinfusion
Sponsors
Maastricht University Medical Center
Rennes University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of chyme reinfusion in patients with a double enterostomy on plasma levels of FGF19 | Week 7 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Effect of chyme reinfusion in patients with a double enterostomy on plasma bile salt levels | Week 7 | Measurement of bile salt |
| 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 | — |
| Assessment of smooth muscle specific (SM) 22 plasma levels | Week 7 | — |
Countries
France, Netherlands
Outcome results
None listed