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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2018-07-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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)

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Changes in Bile Acid Homeostasis and Stool Habits After Cholecystectomy

NCT03168555

Bile Acid Malabsorption Cholelithiasis

COMPLETED PHASE4

Examination of the Metabolic Effects of Direct Bile Salt Delivery to the Ileum in Humans

NCT03201952

Glucose Intolerance Gastric Bypass Surgery

TERMINATED PHASE1

Biliary Excretion of Conjugated Bile Acids in Humans Measured by 11C-cholylsarcosine PET/CT

NCT01879735

Cholestasis Primary Sclerosing Cholangitis Primary Biliary Cirrhosis

COMPLETED PHASE1

PET/CT Scans Using the Tracer 11C-Csar, a Bile Acid Analog, to Depict and Visualize Cholestatic Disorders in Patients with Genetic Liver Disorders and Healthy Individuals

NCT06610695

Cholestasis Genetic Liver Disorder

ENROLLING_BY_INVITATION

Intestinal Microbiome Composition in Infants With Biliary Atresia (BA)

NCT03890536

Biliary Atresia Intrahepatic Cholestases Normal Controls

WITHDRAWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Double Enterostomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Double enterostomy

Group Type OTHER

Chyme reinfusion

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Chyme reinfusion

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No