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

Primary Purpose

Small Intestinal Bacterial Overgrowth, Liver Cirrhosis

Status
Terminated
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Rifaximin
Placebo
Sponsored by
Coordinación de Investigación en Salud, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Intestinal Bacterial Overgrowth focused on measuring Rifaximin, Minimal hepatic encephalopathy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centro Médico Nacional Siglo XXI

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Rifaximin

Placebo

Arm Description

Patients will receive per day 1200 mg of rifaximin

Patients will receive a placebo of rifaximin

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Reversal of minimal hepatic encephalopathy
Analyze the number of patients who reverts the minimal hepatic encephalopathy

Full Information

First Posted
May 5, 2015
Last Updated
March 7, 2022
Sponsor
Coordinación de Investigación en Salud, Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT02439307
Brief Title
Effycacy of Rifaximin on Reverse Minimal Hepatic Encephalopathy and Elimation Small Intestinal Bacterial
Official Title
Effect of Rifaximin on Minimal Hepatic Encephalopathy and Small Intestinal Bacterial Overgrowth in Patients With Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated because of the reconversion of the hospital to care for patients with COVID19. For this reason, it was not possible to continue recruiting and monitoring patients for this clinical study.
Study Start Date
February 28, 2017 (Actual)
Primary Completion Date
July 26, 2021 (Actual)
Study Completion Date
July 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Coordinación de Investigación en Salud, Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Intestinal Bacterial Overgrowth, Liver Cirrhosis
Keywords
Rifaximin, Minimal hepatic encephalopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rifaximin
Arm Type
Active Comparator
Arm Description
Patients will receive per day 1200 mg of rifaximin
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive a placebo of rifaximin
Intervention Type
Drug
Intervention Name(s)
Rifaximin
Other Intervention Name(s)
Antibiotic
Intervention Description
1200 mg of rifaximin for 2 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Action lacks substance
Intervention Description
Placebo for 2 weeks
Primary Outcome Measure Information:
Title
Reversal of small intestinal bacterial overgrowth
Description
Analyze the number of patients who reverts the small intestinal bacterial overgrowth after the study
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Quality of life improvement
Description
Analyze the number of patients who improve the record of quality of life, that will be evaluated with the Chronic Liver Disease Questionnaire
Time Frame
2 weeks
Title
Reversal of minimal hepatic encephalopathy
Description
Analyze the number of patients who reverts the minimal hepatic encephalopathy
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Segundo Moran
Organizational Affiliation
Instituto Mexicano del Seguro Social
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Médico Nacional Siglo XXI
City
Mexico
State/Province
Ciudad De Mexico
ZIP/Postal Code
06720
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No

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

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