NCT03511573

Brief Summary

The existence of an adipose tissue microbiota causally involved in the triggering of a low grade inflammation could resemble what observed in liver fibrosis. To generate microbial hypotheses putatively responsible for the onset of liver fibrosis we sequenced the 16SrDNA gene from liver biopsies from 36 obese patients (ROLIVER cohort) and describe an original mathematical approach to decipher signatures of early stage of liver fibrosis F0, F1, F2.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 30, 2018

Completed
Last Updated

April 30, 2018

Status Verified

April 1, 2018

Enrollment Period

3 years

First QC Date

April 18, 2018

Last Update Submit

April 18, 2018

Conditions

To Generate Microbial Hypotheses Putatively Responsible for the Onset of Liver Fibrosis

Outcome Measures

Primary Outcomes (1)

  • a positive or a negative linear regression between 16SrDNA sequences and liver fibrosis scores

    the frequency of some 16SrDNA in the liver should be positively or negatively correlated with the score of liver fibrosis

    36 months

Interventions

bariatric and other laparoscopic surgeryPROCEDURE

We have obtained liver samples during laparoscopic surgical procedures in the majority of cases. The majority of laparoscopic procedures were sleeve gastrectomies performed for morbid obesity as a primary restrictive procedure; in 5 cases the liver biopsies were performed during laparoscopic cholecystectomies.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Eligible participants were males or females with a BMI over 35 and comorbidities or over 40.

You may qualify if:

  • bariatric patients
  • morbid obesity patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 18, 2018

First Posted

April 30, 2018

Study Start

January 1, 2014

Primary Completion

December 31, 2016

Study Completion

January 31, 2017

Last Updated

April 30, 2018

Record last verified: 2018-04