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RiMINI - the influence of rifaximin on minimal hepatic encephalopathy (MHE) and on the intestinal microbiome in patients with liver cirrhosis: study protocol for a randomized controlled trial.
Schulz, Christian Schütte, Kerstin Kropf, Siegfried Schmitt, Friedhelm C Vasapolli, Riccardo Kliegis, Leon M Riegger, Antonia Malfertheiner, Peter
Schulz, Christian
Schütte, Kerstin
Kropf, Siegfried
Schmitt, Friedhelm C
Vasapolli, Riccardo
Kliegis, Leon M
Riegger, Antonia
Malfertheiner, Peter
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Abstract
Hepatic encephalopathy (HE) is a clinically significant complication of liver cirrhosis impacting on the patients' quality of life. Minimal hepatic encephalopathy (MHE) is diagnosed by psychometric tests, found in up to 80 % of patients with liver cirrhosis and carries a high risk of progression to overt HE. Continuous therapy with rifaximin in combination with lactulose significantly reduces the risk of overt HE, recurrence of HE and HE-related hospitalizations in randomized, double-blind, placebo-controlled clinical trials. Rifaximin is approved for the therapy of overt HE in Germany. Treatment with lactulose has been shown to improve cognitive functions in patients with liver cirrhosis. Data from prospective clinical trials comparing the efficacy of rifaximin alone against a combination of rifaximin and lactulose in the treatment of MHE are scarce. Changes in the microbiome of the upper and lower gastrointestinal tract as a result of therapy with rifaximin have not yet been addressed in clinical studies.
Citation
RiMINI - the influence of rifaximin on minimal hepatic encephalopathy (MHE) and on the intestinal microbiome in patients with liver cirrhosis: study protocol for a randomized controlled trial. 2016, 17 (1):111 Trials
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Journal
PubMed ID
PubMed Central ID
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Article
Language
en
Description
Series/Report no.
ISSN
1745-6215