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.

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