Clinical trial NCT02439307: Effycacy of Rifaximin on Reverse Minimal Hepatic Encephalopathy and Elimation Small Intestinal Bacterial
Official title: Effect of Rifaximin on Minimal Hepatic Encephalopathy and Small Intestinal Bacterial Overgrowth in Patients With Cirrhosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Small Intestinal Bacterial Overgrowth
Liver Cirrhosis
Keywords: Rifaximin
Minimal hepatic encephalopathy
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Sponsor class: OTHER_GOV
First posted: 2015-05-08
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Reversal of small intestinal bacterial overgrowth
timeFrame: 2 weeks
Secondary outcomes:
measure: Quality of life improvement
timeFrame: 2 weeks
measure: Reversal of minimal hepatic encephalopathy
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Centro Médico Nacional Siglo XXI
state: Ciudad De Mexico
Study officials:
affiliation: Instituto Mexicano del Seguro Social
name: Segundo Moran
role: PRINCIPAL_INVESTIGATOR
References: