Microbiota Study in Liver Transplanted Patients

NCT ID: NCT03507140

Last Updated: 2025-04-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 64 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-16
• Study Completion Date: 2024-03-27

Brief Summary

Many studies describe the relationship between microbiota alteration and the occurrence of metabolic, alcoholic or inflammatory liver diseases. Nevertheless, the modifications of microbiota during liver transplantation (LT) as well as its implication are poorly studied. Similarly, only the intestinal microbiota is studied in this context, and no data are available on the biliary microbiota, even if it is known that bile microbiota can interfere with hepatobiliary diseases.

This study proposes a clinical and biological in-depth follow-up with multiple sampling of liver transplanted patients to study biliary and intestinal microbiota alterations along LT, as well as bile acids metabolism in corresponding fluids.

Indeed, in recipient samples as saliva, blood, urine, and feces can be taken before LT, and surgeons can easily perform bile sampling during LT. In donors all samples can be taken during liver removal. This offers the opportunity to have a microbiotic landscape of individuals without liver disease (donor), and patients suffering from a chronic liver disease or a liver cancer before and after transplantation.

Also, in Grenoble University hospital, in case of biliary anastomotic incongruence, a biliary stent is placed during LT in 60% of recipients. This stent is removed by endoscopic retrograde cholangiopancreatography (ERCP) within 6 months after LT, offering a second opportunity to obtain bile samples in transplanted patients, after the early post-LT period. Patients who do not require a biliary stent will also be included for the study of secondary objectives, as intestinal microbiota is very poorly characterized in liver transplanted patients too. A portion of the patients without biliary stent, may also develop an anastomotic biliary stricture requiring an ERCP. If this ERCP is realized within the follow-up period of the study, the patient will also be included in the primary objective of the study.

These multiple and sequential samples will allow a complete analysis of microbiota changes in LT patients and aim to answer to 3 questions:

1. What are the modifications of intestinal and biliary microbiomes during LT?

2. What is the influence of bile acids' composition on intestinal and biliary microbiota?

3. What are the relationships between microbiome alterations and the emergence of LT complications?

Conditions

Cirrhosis; Hepatocellular Carcinoma; Liver Transplant; Microbiota

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Multiple sampling

Bile, saliva, feces, urine et blood samples before and after liver transplantation in recipients.

Bile, saliva, feces, urine et blood samples during liver removal in donors.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Recipients:

• Age ≥ 18 years old
• Absence of LT contraindications
• Patient undergoing liver transplantation
• Patient legally able to give written consent.
• Person affiliated to social security

Donors:

Cadaveric-donor liver transplantation

Exclusion Criteria

• Living-related liver transplantation
• LT contraindications
• All subjects protected by articles L1121-5 and L1121-8 of French public health law (Subject under administrative or judicial control, person who are protected under the act, person hospitalized without their consent, prisoners and pregnant or breast-feeding women).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gael ROTH, MD

Role: PRINCIPAL_INVESTIGATOR

GRENOBLE ALPES UNIVERSITY HOSPITAL

Locations

CHU de GRENOBLE ALPES

Grenoble, , France

Countries

France

Other Identifiers

38RC17.332

Identifier Type: -

Identifier Source: org_study_id