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

Double Enterostomy Clinical Trial

— RESCUE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02990195
• Other study ID #: 35RC16_8914_RESCUE
• Status: Completed
• Phase: Phase 2
• Start date: December 1, 2016
• Est. completion date: July 2, 2018

Study information

• Verified date: May 2023
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: July 2, 2018
• Est. primary completion date: July 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Double Enterostomy

Intervention

Other:
• Chyme reinfusion

Locations

Country	Name	City	State
France	CHU de Rennes	Rennes
France	Clinique Saint Yves	Rennes
Netherlands	Maastricht University, Research Laboratories at the Department of General Surgery	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Rennes University Hospital	Maastricht University Medical Center

Countries where clinical trial is conducted

France,  Netherlands, 

References & Publications (1)

Koelfat KVK, Picot D, Chang X, Desille-Dugast M, van Eijk HM, van Kuijk SMJ, Lenicek M, Layec S, Carsin M, Dussaulx L, Seynhaeve E, Trivin F, Lacaze L, Thibault R, Schaap FG, Olde Damink SWM. Chyme Reinfusion Restores the Regulatory Bile Salt-FGF19 Axis i — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of chyme reinfusion in patients with a double enterostomy on plasma levels of FGF19		Week 7
Secondary	Effect of chyme reinfusion in patients with a double enterostomy on plasma bile salt levels	Measurement of bile salt	Week 7
Secondary	Assessment of 7-alpha-hydroxy-4-cholesten-3-one (C4) plasma levels		Week 7
Secondary	Assessment of bile salt composition in plasma		Week 7
Secondary	Assessment of microbiotic profiling		Week 7
Secondary	Assessment of citrulline plasma levels		Week 7
Secondary	Assessment of intestinal-fatty acid binding protein (I-FABP) plasma levels		Week 7
Secondary	Assessment of smooth muscle specific (SM) 22 plasma levels		Week 7
Secondary	Effect of chyme reinfusion in patients with a double enterostomy on liver function		Week 7
Secondary	Assessment of lipopolysaccharide binding protein (LBP) plasma levels		Week 7
Secondary	Assessment of plasma levels of inflammatory cytokines interleukin-6 (IL-6)		Week 7
Secondary	Assessment of plasma levels of tumor necrosis factor-alpha (TNF-alpha)		Week 7