TerminatedNot Applicable

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

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.

Mexico11 participantsStarted 2017-02-28

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Reversal of small intestinal bacterial overgrowth

Timeframe: 2 weeks

Trial details

NCT IDNCT02439307

SponsorCoordinación de Investigación en Salud, Mexico

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2021-07-26