An interventional study of Rifaximin and Placebo in Small Intestinal Bacterial Overgrowth and Liver Cirrhosis, sponsored by Coordinación de Investigación en Salud, Mexico. Terminated at 1 site in Mexico. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-03-21.
Sponsored by Coordinación de Investigación en Salud, Mexico · Not applicable, Interventional, and Treatment
A total of 46 patients diagnosed with liver cirrhosis will be recruited. All patients will be evaluated with five psychometric tests and critical flicker frequency to diagnosis minimal hepatic encephalopathy (MHE). A breath test sample will be performed in all patients with MHE with 10 g of lactulose to establish the diagnosis of small intestinal bacterial overgrowth (SIBO). Patients diagnosed with EHM and SIBO will be randomized to receive per day 1200 mg of rifaximin (group A) or placebo (group B) for 2 weeks. A complete medical history, nutritional assessment, biochemical studies, and evaluation of quality of life will be performed in all patients included in the study. Besides the initial visit, patients will receive subsequent care 2, 4, 8, 12, and 24 weeks after the beginning of the study.
MHE impairs the quality of life, increases the risk of motor vehicle accidents, and mortality. Currently, there is no consensus on treatment and yet there are few proven treatment options. Among the factors associated with MHE, is the small intestinal bacterial overgrowth (SIBO) present in 38.6% of patients with MHE. Rifaximin is a broad spectrum antimicrobial administered orally, with low risk of inducing bacterial resistance, and has been used in the treatment of MHE. It is unknown if the beneficial effect on MHE is associated with the elimination of SIBO and its efficacy when administered in patients with simultaneous diagnosis of MHE and SIBO was never been evaluated. The aim of our study is to evaluate the effect of rifaximin on MHE and SIBO in patients with cirrhosis.
1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.
This study's enrollment of 11 is below the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Coordinación de Investigación en Salud, Mexico is the lead sponsor of 95 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive per day 1200 mg of rifaximin
Drug: Rifaximin
Patients will receive a placebo of rifaximin
Drug: Placebo
1200 mg of rifaximin for 2 weeks.
Also known as: Antibiotic
Placebo for 2 weeks
Also known as: Action lacks substance
Reversal of small intestinal bacterial overgrowth
Analyze the number of patients who reverts the small intestinal bacterial overgrowth after the study
Time frame: 2 weeks
Quality of life improvement
Analyze the number of patients who improve the record of quality of life, that will be evaluated with the Chronic Liver Disease Questionnaire
Time frame: 2 weeks
Reversal of minimal hepatic encephalopathy
Analyze the number of patients who reverts the minimal hepatic encephalopathy
Time frame: 2 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Coordinación de Investigación en Salud, Mexico