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

Rennes University Hospital

Status and phase

Completed

Phase 2

Conditions

Double Enterostomy

Treatments

Other: Chyme reinfusion

Study type

Interventional

Funder types

Other

Identifiers

NCT02990195

35RC16_8914_RESCUE

Details and patient eligibility

About

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)

Full 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.

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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