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

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

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.

Study Overview

• Status: Terminated
• Conditions: Liver Cirrhosis; Small Intestinal Bacterial Overgrowth
• Intervention / Treatment: Drug: Rifaximin; Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Ciudad De Mexico
    • Mexico, Ciudad De Mexico, Mexico, 06720
      • Centro Médico Nacional Siglo XXI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Coordinación de Investigación en Salud, Mexico
• Investigators: Principal Investigator: Segundo Moran, Instituto Mexicano del Seguro Social

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2017
• Primary Completion (Actual): July 26, 2021
• Study Completion (Actual): July 26, 2021

Study Registration Dates

• First Submitted: May 5, 2015
• First Submitted That Met QC Criteria: May 6, 2015
• First Posted (Estimate): May 8, 2015

Study Record Updates

• Last Update Posted (Actual): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Minimal hepatic encephalopathy; Rifaximin
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Liver Diseases; Brain Diseases, Metabolic; Fibrosis; Liver Cirrhosis; Hepatic Encephalopathy; Brain Diseases; Anti-Infective Agents; Gastrointestinal Agents; Rifaximin; Anti-Bacterial Agents
• Other Study ID Numbers: F-CNIC-2013-55

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No