Clinical Trial Details

Trial ID: L0673
Source ID: EUCTR2010-021515-17-GB
Associated Drug: Rifaximin
Title: RiFL: Rifaxamin in Fatty Liver Disease. Does Modulation of Gut Microbiota Reduce Hepatic Inflammation in Non-Alcoholic Steatohepatitis (NASH)? - Rifaximin in Fatty Liver v2.0
Acronym: --
Status: Not Recruiting
Study Results: No Results Available
Results: --
Conditions: Non-alcoholic steatohepatitis (NASH) <br>MedDRA version: 12.1 Level: LLT Classification code 10053219 Term: non-alcoholic steatohepatitis
Interventions: <br>Trade Name: Normix<br>Product Name: Rifaximin<br>Product Code: 025300029<br>Pharmaceutical Form: Tablet<br><br>
Outcome Measures: Main Objective: To assess whether the antibiotic, Rifaximin, reduces liver inflammation in non-alcoholic steatohepatitis (NASH).;Secondary Objective: To determine whether Rifaximin's effect on bowel flora leads to: <br>1. Reduction in liver fat<br>2. Change in resistance to the energy storage hormone, insulin<br>3. Change in mediators of inflammation (cytokines)<br><br>To determine how changes in the gut bacteria related to the measures stated above.;Primary end point(s): The change in serum alanine aminotransferase level after treatment with Rifaximin.nan
Sponsor/Collaborators: Imperial College London
Gender: All
Age: nannan
Phases: Not applicable
Enrollment: --
Study Type: Interventional clinical trial of medicinal product
Study Designs: Controlled: yes Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes
Start Date: 08/10/2010
Completion Date: --
Results First Posted: --
Last Update Posted: 5 November 2012
Locations: United Kingdom
URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-021515-17