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

NCT02439307 | Terminated

• 1 other identifier: F-CNIC-2013-55
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Small Intestinal Bacterial Overgrowth; Liver Cirrhosis

Keywords

Rifaximin; Minimal hepatic encephalopathy

Outcome Measures

Primary Outcomes (1)

• Reversal of small intestinal bacterial overgrowth

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

  2 weeks

Secondary Outcomes (2)

• Quality of life improvement

  2 weeks

• Reversal of minimal hepatic encephalopathy

  2 weeks

Study Arms (2)

Rifaximin

ACTIVE COMPARATOR

Patients will receive per day 1200 mg of rifaximin

Drug: Rifaximin

Placebo

PLACEBO COMPARATOR

Patients will receive a placebo of rifaximin

Drug: Placebo

Interventions

Rifaximin DRUG

1200 mg of rifaximin for 2 weeks.

Also known as: Antibiotic

Rifaximin

Placebo DRUG

Placebo for 2 weeks

Also known as: Action lacks substance

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead

Study Sites (1)

Centro Médico Nacional Siglo XXI

Mexico City, Mexico City, 06720, Mexico

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Rifaximin; Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Segundo Moran

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Titular B

Study Record Dates

• First Submitted: May 5, 2015
• First Posted: May 8, 2015
• Study Start: February 28, 2017
• Primary Completion: July 26, 2021
• Study Completion: July 26, 2021
• Last Updated: March 21, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)