Effect of Rifaximin on Minimal Hepatic Encephalopathy and Small Intestinal Bacterial Overgrowth in Patients With Cirrhosis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Reversal of small intestinal bacterial overgrowth
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Rifaximin
Patients will receive per day 1200 mg of rifaximin
干预措施: Rifaximin (Drug)
Placebo
Patients will receive a placebo of rifaximin
干预措施: Placebo (Drug)
结局指标
主要结局
Reversal of small intestinal bacterial overgrowth
时间窗: 2 weeks
Analyze the number of patients who reverts the small intestinal bacterial overgrowth after the study
次要结局
- Quality of life improvement(2 weeks)
- Reversal of minimal hepatic encephalopathy(2 weeks)
研究者
Segundo Moran Villota
Titular B
Coordinación de Investigación en Salud, Mexico