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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02439307
• Other study ID #: F-CNIC-2013-55
• Status: Terminated
• Phase: N/A
• Start date: February 28, 2017
• Est. completion date: July 26, 2021

Study information

• Verified date: March 2022
• Source: Coordinación de Investigación en Salud, Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: July 26, 2021
• Est. primary completion date: July 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Fibrosis
• Hepatic Encephalopathy
• Liver Cirrhosis
• Small Intestinal Bacterial Overgrowth

Intervention

Drug:
• Rifaximin
1200 mg of rifaximin for 2 weeks.
• Placebo
Placebo for 2 weeks

Locations

Country	Name	City	State
Mexico	Centro Médico Nacional Siglo XXI	Mexico	Ciudad De Mexico

Sponsors (1)

Lead Sponsor	Collaborator
Coordinación de Investigación en Salud, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reversal of small intestinal bacterial overgrowth	Analyze the number of patients who reverts the small intestinal bacterial overgrowth after the study	2 weeks
Secondary	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
Secondary	Reversal of minimal hepatic encephalopathy	Analyze the number of patients who reverts the minimal hepatic encephalopathy	2 weeks