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

• Status: Suspended
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Coordinación de Investigación en Salud, Mexico
• Treatments: Anti-Bacterial Agents; Rifamycins; Rifaximin

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