CTRI/2008/091/000268已完成2 期
Supplementation with a probiotic preparation, VSL#3® as a support pharmaceutical therapy in cirrhotic patients for the treatment of minimal hepatic encephalopathy (MHE). A double-blind, randomized, placebo controlled study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Male and female patients aged more than 16 years;
- •2.Diagnosis of cirrhosis based on standard clinical and biochemical criteria and, possibly, biopsy proven;
- •3.No long-term antibiotic treatment needed
- •4.Able to provide written informed consent
排除标准
- •1.Alcohol consumption or substance abuse within the last 3 months
- •2.Overt HE or a history of overt HE
- •3.Renal insufficiency with creatinine greater than 1.5 mg/dL (233 μmol/L)
- •4.Ongoing treatment for HE, including treatment with antibiotics (possible treatments should have been stopped at least one month before)
- •5.Need to take long term antibiotics for any reason
- •6.Pregnant females, or females planning to become pregnant, or nursing
- •7.Patients who are unable or unwilling to provide informed consent
- •8.Patients who are taking benzodiazepines, narcotics, anti-depressants, or anti-psychotic medication (previous medication with these drugs should have stopped by one month or more)
- •9.Patients with history of shunt surgery or transjugular intrahepatic portosystemic shunt (TIPSS) for portal hypertension
- •10.Patients with any other organic brain disease, including dementia from any cause, mental retardation, Wilson?s disease, previous stroke, TIA, etc.
- •11.Severe medical problems such as congestive heart failure, pulmonary disease, neurological or psychiatric disorder, etc., that could influence quality-of-life measurement;
- •12.Inability to perform NP tests due to bad vision
- •13.Patients with gastrointestinal dysfunction (motility, prior resection/surgery, obstruction)
- •14.Gastrointestinal bleeding within 30 days
- •15.Serious infection (e.g. peritonitis) within 30 days
- •16.Known hepatocellular carcinoma or AFP>400
研究者
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