CTRI/2019/02/017538招募中未知
Fecal microbiota transplantation in severe alcoholic hepatitis- assessment of impact on prognosis and short-term outcome.
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- PGIMER
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
- •Alcoholic hepatitis, as defined by:
- •1. Rapid development or worsening of jaundice and liver-related complications with serum total bilirubin more than 3 milligrams per decilitre.
- •2.Aspartate aminotransferase and alanine aminotransferase elevated to more than one and half times the upper limit of normal but less than 400 IU per litre with AST to ALT ratio over 1.5.
- •3.Documentation of persistent heavy alcohol use until 8 weeks before onset of symptoms.
- •4.Alcohol Consumption in female over 40 grams per day for at least 6 months and in males over 60 grams per day for at least 6 months.
- •5.Maddreys Discriminant Function Score of more than 32 OR
- •6.A patient of alcoholic hepatitis who will present with grade 1 or 2 of hepatic encephalopathy.
排除标准
- •1. Intestinal paralysis, lack of bowel sounds, intestinal perforation.
- •2.Uncontrolled infections.
- •3.Uncontrolled upper gastrointestinal bleeding.
- •4.Grade 3,4 hepatic encephalopathy.
- •5.Hepatic or extrahepatic malignancy.
- •6.Maddreyâ??s Discriminant Function (mDF) >90 or MELD >30.
- •7.Autoimmune hepatitis, Wilsonâ??s disease, suspected drug induced liver injury.
- •8.Patients who are aged >60 years
- •9.WBC count <1000 cells/mm3
- •10.Pregnancy or nursing.
- •11.Human Immunodeficiency Virus (HIV), HBV, HCV infection.
- •12.Patientâ??s unwillingness to participate in the study.
- •13.Any other condition which, in the opinion of the investigator, would impede compliance or hinder completion of the study.
研究者
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