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

May 22, 2023 updated by: Rennes University Hospital
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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France, 35033
        • CHU de Rennes
      • Rennes, France, 35033
        • Clinique Saint Yves
  • Netherlands
      • Maastricht, Netherlands
        • Maastricht University, Research Laboratories at the Department of General Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Double enterostomy
Other: Chyme reinfusion

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Collaborators

Maastricht University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

July 2, 2018

Study Completion (Actual)

July 2, 2018

Study Registration Dates

First Submitted

December 6, 2016

First Submitted That Met QC Criteria

December 12, 2016

First Posted (Estimate)

December 13, 2016

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 35RC16_8914_RESCUE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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