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

Coordinación de Investigación en Salud, Mexico

Status

Terminated

Conditions

Liver Cirrhosis

Small Intestinal Bacterial Overgrowth

Treatments

Drug: Placebo

Drug: Rifaximin

Study type

Interventional

Funder types

Other

Identifiers

NCT02439307

F-CNIC-2013-55

Details and patient eligibility

About

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.

Full 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.

Enrollment

11 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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