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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-28

Study Completion Date

2021-07-26

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.

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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.

Conditions

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Small Intestinal Bacterial Overgrowth Liver Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Rifaximin

Patients will receive per day 1200 mg of rifaximin

Group Type ACTIVE_COMPARATOR

Rifaximin

Intervention Type DRUG

1200 mg of rifaximin for 2 weeks.

Placebo

Patients will receive a placebo of rifaximin

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo for 2 weeks

Interventions

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Rifaximin

1200 mg of rifaximin for 2 weeks.

Intervention Type DRUG

Placebo

Placebo for 2 weeks

Intervention Type DRUG

Other Intervention Names

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Antibiotic Action lacks substance

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No