CTRI/2016/08/007178已完成未知
Fecal Microbiota Therapy in Severe Alcoholic Hepatitis Prospective Interventional Study
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 29
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) All patients with a diagnosis of severe alcoholic hepatitis who are steroid ineligible, are non responders or are intolerant
- •2) Severe alcoholic hepatitis defined as Maddrey Discriminant Function Score with Serum Bilirubin in mg per dl of more than 32 or a patient of alcoholic hepatitis who presents with any grade of hepatic encephalopathy
- •3) Conventional therapy defined as oral steroid therapy with 40mg once a day for 7 days.
- •4) Failure of therapy defined as a Lille Model Score of more than 0.45 at day 8 of steroid therapy OR emergence of complications of steroid therapy or intolerance to steroid protocol or ineligible for steroid therapy.
- •5) Ineligibility for steroid therapy includes Renal dysfunction, evidence of active sepsis or foci of sepsis, gastro intestinal bleeding and disseminated intravascular coagulation, steroid intolerance, steroid related uncontrolled hyperglycemia which precludes therapy, uncontrolled diabetes mellitus.
- •6) A Psychologist will be arranged for recipients who are on Fecal Transplant protocol for psychological support throughout the period of one week, during which the transplant procedure will be performed
- •i) Healthy persons who are willing for faeces donation have to be a close family member
- •ii) The donor will be required to give a written consent for faeces donation
- •iii) Once consent is taken, the donor will have to undergo the following screening measures:
- •a) Clostridium difficile toxins A and B by EIA
- •b) Routine bacterial culture for enteric pathogens in stool
- •c) Ova and parasites
- •d) Blood serology for viruses, human immunodeficiency virus HAV IgM, HBsAg, anti HCV Ab.
排除标准
- •1)Active gastrointestinal bleeding
- •2)Intracranial bleeding
- •3)Multi-organ failure on mechanical ventilation
- •4)On high inotropic support
- •5)Paralytic ileus
- •6)Pregnancy
- •8)Failure to provide consent
- •9)Have abnormal bowel motions
- •10)Have abdominal complaints
- •11)Have symptoms indicative of irritable bowel syndrome
- •12)Have extensive travel history or predisposing factors for potentially transmittable diseases
- •13)Have chronic alcohol intake
- •14)Have history of substance abuse
- •15)Are less than 18 years or more than 60 years of age
- •16)Have HIV and Hepatitis Risk factors
- •17)Have enteric infections
- •18)Have inflammatory bowel disease history
- •19)Have chronic constipation or diarrhea
- •20)Have prior abdominal surgery or GI neoplasms
- •21)Have Metabolic Syndrome
- •22)Have Systemic Autoimmunity
- •23)Have atopic diseases
- •24)Have food and respiratory allergies
- •25)Have any chronic pain syndromes
- •26)Have chronic Neurologic disorders
- •27)Have Neurodevelopmental disorders
- •28)Have had antibiotics for any indication taken within the last 2 months
研究者
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