- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03507140
Microbiota Study in Liver Transplanted Patients (BIM-LT)
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:
- What are the modifications of intestinal and biliary microbiomes during LT?
- What is the influence of bile acids' composition on intestinal and biliary microbiota?
- What are the relationships between microbiome alterations and the emergence of LT complications?
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Gael ROTH, MD
- Phone Number: +33 476 766 739
- Email: groth@chu-grenoble.fr
Study Locations
-
-
-
Grenoble, France, 38100
- Recruiting
- CHU de Grenoble Alpes
-
Contact:
- Gaël ROTH
- Email: GRoth@chu-grenoble.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
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
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
Sponsor
Investigators
- Principal Investigator: Gael ROTH, MD, Grenoble Alpes University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 38RC17.332
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Hepatocellular Carcinoma
-
Roswell Park Cancer InstituteNational Comprehensive Cancer NetworkCompletedAdvanced Adult Hepatocellular Carcinoma | Localized Non-Resectable Adult Hepatocellular Carcinoma | Stage IIIA Hepatocellular Carcinoma | Stage IIIB Hepatocellular Carcinoma | Stage IIIC Hepatocellular Carcinoma | Stage IVA Hepatocellular Carcinoma | Stage IVB Hepatocellular Carcinoma | Stage III... and other conditionsUnited States
-
Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)RecruitingUnresectable Hepatocellular Carcinoma | Stage III Hepatocellular Carcinoma AJCC v8 | Stage IIIA Hepatocellular Carcinoma AJCC v8 | Stage IV Hepatocellular Carcinoma AJCC v8 | Stage IVA Hepatocellular Carcinoma AJCC v8 | Stage IVB Hepatocellular Carcinoma AJCC v8 | BCLC Stage B Hepatocellular Carcinoma and other conditionsUnited States
-
Roswell Park Cancer InstituteMerck Sharp & Dohme LLCActive, not recruitingAdvanced Adult Hepatocellular Carcinoma | Child-Pugh Class A | Stage III Hepatocellular Carcinoma | Stage IIIA Hepatocellular Carcinoma | Stage IIIB Hepatocellular Carcinoma | Stage IIIC Hepatocellular Carcinoma | Stage IV Hepatocellular Carcinoma | Stage IVA Hepatocellular Carcinoma | Stage IVB Hepatocellular...United States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedUnresectable Hepatocellular Carcinoma | Advanced Adult Hepatocellular Carcinoma | Stage IIIB Hepatocellular Carcinoma AJCC v7 | Stage IIIC Hepatocellular Carcinoma AJCC v7 | BCLC Stage C Hepatocellular Carcinoma | Stage IV Hepatocellular Carcinoma AJCC v7 | Stage III Hepatocellular Carcinoma AJCC... and other conditionsUnited States
-
Academic and Community Cancer Research UnitedNational Cancer Institute (NCI); Genentech, Inc.RecruitingUnresectable Hepatocellular Carcinoma | Stage III Hepatocellular Carcinoma AJCC v8 | Stage IIIA Hepatocellular Carcinoma AJCC v8 | Stage IV Hepatocellular Carcinoma AJCC v8 | Stage IVA Hepatocellular Carcinoma AJCC v8 | Stage IVB Hepatocellular Carcinoma AJCC v8 | Stage IIIB Hepatocellular Carcinoma... and other conditionsUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)RecruitingUnresectable Hepatocellular Carcinoma | Stage III Hepatocellular Carcinoma AJCC v8 | Stage IIIA Hepatocellular Carcinoma AJCC v8 | Stage IV Hepatocellular Carcinoma AJCC v8 | Stage IVA Hepatocellular Carcinoma AJCC v8 | Stage IVB Hepatocellular Carcinoma AJCC v8 | BCLC Stage B Hepatocellular Carcinoma and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedUnresectable Hepatocellular Carcinoma | Advanced Adult Hepatocellular Carcinoma | Recurrent Hepatocellular Carcinoma | Stage IIIB Hepatocellular Carcinoma AJCC v7 | Stage IIIC Hepatocellular Carcinoma AJCC v7 | Stage IV Hepatocellular Carcinoma AJCC v7 | Stage III Hepatocellular Carcinoma AJCC v7 and other conditionsUnited States, Canada, Puerto Rico
-
Mayo ClinicNational Cancer Institute (NCI)RecruitingAdvanced Hepatocellular Carcinoma | BCLC Stage B Hepatocellular Carcinoma | BCLC Stage C Hepatocellular Carcinoma | Metastatic Hepatocellular Carcinoma | BCLC Stage A Hepatocellular CarcinomaUnited States
-
Northwestern UniversityBristol-Myers Squibb; National Cancer Institute (NCI)CompletedStage IIIA Hepatocellular Carcinoma | Stage IIIB Hepatocellular Carcinoma | Stage IIIC Hepatocellular Carcinoma | Stage IVA Hepatocellular Carcinoma | Stage IVB Hepatocellular CarcinomaUnited States
-
Edward KimBristol-Myers Squibb; National Cancer Institute (NCI)TerminatedUnresectable Hepatocellular Carcinoma | Stage III Hepatocellular Carcinoma AJCC v8 | Stage IIIA Hepatocellular Carcinoma AJCC v8 | Stage IV Hepatocellular Carcinoma AJCC v8 | Stage IVA Hepatocellular Carcinoma AJCC v8 | Stage IVB Hepatocellular Carcinoma AJCC v8 | Stage IIIB Hepatocellular Carcinoma... and other conditionsUnited States
Clinical Trials on Multiple sampling
-
Assistance Publique - Hôpitaux de ParisUnknownSepsis | Acute Circulatory FailureFrance
-
Medical University of South CarolinaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Boston...CompletedIndeterminate Bile Duct StrictureUnited States
-
Assistance Publique Hopitaux De MarseilleCompletedCytomegalovirus InfectionFrance
-
Galapagos NVCompleted
-
Centre Hospitalier Sud FrancilienNot yet recruitingBacteria in Breast MilkFrance
-
Galapagos NVCompleted
-
Centre Hospitalier Universitaire DijonNot yet recruitingRhegmatogenous Retinal DetachmentsFrance
-
University of OxfordZogenix International Limited, Inc., a subsidiary of Zogenix, Inc.WithdrawnDepression | Anxiety | Dravet Syndrome
-
Medical University of GrazJoanneum Research Forschungsgesellschaft mbHCompleted
-
Institut PasteurInstitut National de la Santé Et de la Recherche Médicale, France; University... and other collaboratorsUnknownEncephalitisVietnam, Cambodia, Lao People's Democratic Republic, Myanmar