Effycacy of Rifaximin on Reverse Minimal Hepatic Encephalopathy and Elimation Small Intestinal Bacterial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Rifaximin on Minimal Hepatic Encephalopathy and Small Intestinal Bacterial Overgrowth in Patients With Cirrhosis

Conditions
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Small Intestinal Bacterial Overgrowth, Liver Cirrhosis

Intervention / Treatment
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* Drug: Rifaximin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of cirrhosis of any etiology Men and women between 18 and 70 years. Patients diagnosed with minimal hepatic encephalopathy and small intestinal bacterial overgrowth Right-holders of the Mexican Social Security Institute Patients who agree to participate in the study and signed the informed consent Exclusion Criteria: Recent history of alcohol abuse and/or drugs (less than 6 weeks). Illiterate Alcoholic cirrhosis History and/or diagnosis of overt hepatic encephalopathy Consumption of psychotropic medications (benzodiazepines, antiepileptics) Patients under treatment with lactulose, lacitol, rifaximin, neomycin, metronidazole and/or fiber supplements. History of chronic renal disease or heart failure Patients with gastrointestinal bleeding History of neurological or psychiatric disorders that affect the ability to develop neuropsychological tests Patients with diarrhea Diagnosis of liver cancer Patients with ophthalmologic disorders Patients taking antibiotics 30 days before the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rifaximin<br>Patients will receive per day 1200 mg of rifaximin | Drug: Rifaximin<br>* 1200 mg of rifaximin for 2 weeks.<br>* Other names: Antibiotic;|
| Placebo Comparator: Placebo<br>Patients will receive a placebo of rifaximin | Drug: Placebo<br>* Placebo for 2 weeks<br>* Other names: Action lacks substance;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reversal of small intestinal bacterial overgrowth | Analyze the number of patients who reverts the small intestinal bacterial overgrowth after the study | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 weeks | 
| Reversal of minimal hepatic encephalopathy | Analyze the number of patients who reverts the minimal hepatic encephalopathy | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rifaximin, Minimal hepatic encephalopathy