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

Sponsor
Coordinación de Investigación en Salud, Mexico (Other)
Overall Status
Terminated
CT.gov ID
NCT02439307
Collaborator
(none)
11
1
2
52.9
0.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
11 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Effect of Rifaximin on Minimal Hepatic Encephalopathy and Small Intestinal Bacterial Overgrowth in Patients With Cirrhosis
Actual Study Start Date :
Feb 28, 2017
Actual Primary Completion Date :
Jul 26, 2021
Actual Study Completion Date :
Jul 26, 2021

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Reversal of small intestinal bacterial overgrowth [2 weeks]

      Analyze the number of patients who reverts the small intestinal bacterial overgrowth after the study

    Secondary Outcome Measures

    1. Quality of life improvement [2 weeks]

      Analyze the number of patients who improve the record of quality of life, that will be evaluated with the Chronic Liver Disease Questionnaire

    2. Reversal of minimal hepatic encephalopathy [2 weeks]

      Analyze the number of patients who reverts the minimal hepatic encephalopathy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centro Médico Nacional Siglo XXI Mexico Ciudad De Mexico Mexico 06720

    Sponsors and Collaborators

    • Coordinación de Investigación en Salud, Mexico

    Investigators

    • Principal Investigator: Segundo Moran, Instituto Mexicano del Seguro Social

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Segundo Moran Villota, Titular B, Coordinación de Investigación en Salud, Mexico
    ClinicalTrials.gov Identifier:
    NCT02439307
    Other Study ID Numbers:
    • F-CNIC-2013-55
    First Posted:
    May 8, 2015
    Last Update Posted:
    Mar 21, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Segundo Moran Villota, Titular B, Coordinación de Investigación en Salud, Mexico
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 21, 2022