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

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ClinicalTrials.gov Identifier: NCT02439307
Recruitment Status : Suspended (The hospital was converted to attend only covid19 patients)
First Posted : May 8, 2015
Last Update Posted : July 16, 2020
Sponsor:
Information provided by (Responsible Party):
Segundo Moran Villota, Coordinación de Investigación en Salud, Mexico

Study Description
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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
Small Intestinal Bacterial Overgrowth Liver Cirrhosis Drug: Rifaximin Drug: Placebo Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 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 : February 28, 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Rifaximin

Arms and Interventions
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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 Name: Antibiotic
Placebo Comparator: Placebo
Patients will receive a placebo of rifaximin
 Drug: Placebo
Placebo for 2 weeks
Other Name: Action lacks substance


Outcome Measures
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Primary Outcome Measures :
  1. Reversal of small intestinal bacterial overgrowth [ Time Frame: 2 weeks ]
    Analyze the number of patients who reverts the small intestinal bacterial overgrowth after the study


Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 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 [ Time Frame: 2 weeks ]
    Analyze the number of patients who reverts the minimal hepatic encephalopathy


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02439307


Locations
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Mexico
Centro Médico Nacional Siglo XXI
Mexico, Ciudad De Mexico, Mexico, 06720
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
Investigators
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Principal Investigator: Segundo Moran Instituto Mexicano del Seguro Social
More Information
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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    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Segundo Moran Villota, Coordinación de Investigación en Salud, Mexico:
Rifaximin
Minimal hepatic encephalopathy
Additional relevant MeSH terms:
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Liver Cirrhosis
Hepatic Encephalopathy
Brain Diseases
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Central Nervous System Diseases
Nervous System Diseases
 Liver Failure
Hepatic Insufficiency
Brain Diseases, Metabolic
Metabolic Diseases
Anti-Bacterial Agents
Rifaximin
Anti-Infective Agents
Gastrointestinal Agents