Trial ID: | L0673 |
Source ID: | EUCTR2010-021515-17-GB
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Associated Drug: |
Rifaximin
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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
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Acronym: |
--
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Status: |
Not Recruiting
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Study Results: |
No Results Available
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Results: |
--
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Conditions: |
Non-alcoholic steatohepatitis (NASH) <br>MedDRA version: 12.1
Level: LLT
Classification code 10053219
Term: non-alcoholic steatohepatitis
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Interventions: |
<br>Trade Name: Normix<br>Product Name: Rifaximin<br>Product Code: 025300029<br>Pharmaceutical Form: Tablet<br><br>
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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
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Sponsor/Collaborators: |
Imperial College London
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Gender: |
All
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Age: |
nannan
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Phases: |
Not applicable
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Enrollment: |
--
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Study Type: |
Interventional clinical trial of medicinal product
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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
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Start Date: |
08/10/2010
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Completion Date: |
--
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Results First Posted: |
--
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Last Update Posted: |
5 November 2012
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Locations: |
United Kingdom
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URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-021515-17
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