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Gut Microbiota and Modulation of Liver Damage in NAFLD

NCT02158351 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 44

Last updated 2020-11-20

No results posted yet for this study

Summary

Several experimental data suggest that gut-derived endotoxin and GM composition can act as a "second hit" or insult to convert hepatic SS to NASH and cause both local hepatic and systemic inflammation.This study's aim is to analyze microbiota diversity, providing information both on intestinal microbial composition and on the metabolic processes linked to them. In addition, we will correlate, for the first time, GM composition to hepatic and white adipose tissue gene expression patterns of interest and serum and fecal markers possibly related to impaired fat storage and inflammation. We aim to provide preliminary data to design future intervention studies with pre- or probiotics or bile acid derivatives to prevent/treat inflammation and fibrosis in NAFLD patients.

Conditions

  • Simple Steatosis (SS)
  • Non-alcoholic Steatohepatitis (NASH)
  • Obesity

Interventions

PROCEDURE

liver and white adipose tissue biopsies

Sponsors & Collaborators

  • Göteborg University

    collaborator OTHER

  • University of Roma La Sapienza

    lead OTHER

Principal Investigators

  • Stefano Ginnani Corradini, MD, PhD · Department of Translational and Precision Medicine, "Sapienza", University of Rome

  • Fredrik Backhed, PhD · Wallenberg laboratoriet, Gotebörg, Sweden

  • Frida Leonetti, MD, PhD · University of Roma La Sapienza

  • Gianfranco Silecchia, MD · University of Roma La Sapienza

  • Francesco Gossetti, MD · University of Roma La Sapienza

  • Adriano De Santis, MD · University of Roma La Sapienza

  • Claudio Di Cristofano, MD · University of Roma La Sapienza

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-06-30
Completion
2017-10-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02158351 on ClinicalTrials.gov