Microbiota Study in Liver Transplanted Patients (BIM-LT)

April 17, 2025 updated by: University Hospital, Grenoble

Biliary and Intestinal Microbiota Study in Liver Transplanted Patients

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?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Grenoble, France, 38100
        • CHU de Grenoble Alpes

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients registered on the waiting list fo liver transplantation

Description

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).

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Comparison of the relative abundance of pathobionts and symbionts before and 6 months after liver transplantation, in the bile of recipients.
Time Frame: During LT and 6 months after LT
Beneficial bacterias/pathobionts ratio before and 6 months after liver transplantation in the bile of recipients.
During LT and 6 months after LT

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Comparison of the relative abundance of pathobionts and beneficial bacteria at the time, and 6 months after liver transplantation, in the feces of recipients.
Time Frame: Before LT (6 months maximum) and 6 months after LT
Intestinal beneficial bacterias/pathobionts ratio before and 6 months after liver transplantation in recipients.
Before LT (6 months maximum) and 6 months after LT
Comparison of bile microbial diversity at the time, and 6 months after liver transplantation, in LT recipients.
Time Frame: During LT and 6 months after LT
Proportion of the different microbial populations in recipients' bile.
During LT and 6 months after LT
Comparison of fecal microbial diversity before, and 6 months after liver transplantation, in LT recipients.
Time Frame: Before LT (6 months maximum) and 6 months after LT
Proportion of the different microbial populations in recipients' feces.
Before LT (6 months maximum) and 6 months after LT
Study the correlation between bile microbiota of donors and recipients after LT.
Time Frame: During LT and 6 months after LT
Proportion of the different biliary microbial populations of donors and in their corresponding recipient.
During LT and 6 months after LT
Study the correlation between fecal microbiota of donors and recipients after LT.
Time Frame: Before LT (6 months maximum) and 6 months after LT
Proportion of the different intestinal microbial populations of donors and their corresponding recipient.
Before LT (6 months maximum) and 6 months after LT
Study the relationships between bile microbiota changes and intestinal microbiota modifications in recipients, before and after LT.
Time Frame: Before LT (6 months maximum) and 6 months after LT
Correlation between microbial populations' proportions in bile and in feces in donors and in recipients.
Before LT (6 months maximum) and 6 months after LT
Study the modifications of bile acid profiles in recipients between before and after LT.
Time Frame: Before LT (6 months maximum) and 6 months after LT
Proportions of total, primary and secondary biles acids in urine, feces and bile of donors and recipients.
Before LT (6 months maximum) and 6 months after LT
Study the influence of bile acids'composition on bile microbiota along transplantation.
Time Frame: Before LT (6 months maximum) and 6 months after LT
Correlation between the evolution of pathobionts and beneficial bacterias' proportions in bile and the different bile acids (BA) profiles (proportions of primary and secondary BAs).
Before LT (6 months maximum) and 6 months after LT
Study the influence of bile acids' composition on intestinal microbiota along transplantation.
Time Frame: Before LT (6 months maximum) and 6 months after LT
Correlation between the evolution of pathobionts and beneficial bacterias' proportions in feces and the different bile acids profiles (proportions of primary and secondary BAs) before and after LT.
Before LT (6 months maximum) and 6 months after LT
Study the relationships between microbiota and the emergence of LT complications (post LT infections, acute liver allograft reject, etc).
Time Frame: Before LT (6 months maximum) and 6 months after LT
Correlation between the evolution of pathobionts and beneficial bacterias' proportions in feces and the different bile acids profiles (proportions of primary and secondary BAs).
Before LT (6 months maximum) and 6 months after LT
Biobanking of blood, saliva, bile, feces and urine for further analyses such as metabolomic studies on blood, urine and feces metagenomic studies on saliva, and immunomonitoring on blood.
Time Frame: Before LT (6 months maximum) and 6 months after LT
Before LT (6 months maximum) and 6 months after LT

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Grenoble

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gael ROTH, MD, Grenoble Alpes University Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 16, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 9, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 27, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 5, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 38RC17.332

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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