CTRI/2022/03/041307招募中未知
Fecal Microbiota Therapy in Steroid Ineligible Alcoholic Hepatitis: A Randomized Controlled Trial
试验速览
- 阶段
- 未知
- 状态
- 招募中
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.Steroid ineligible severe alcoholic hepatitis as per definition
- •2.Informed consent
- •3.Age 18 - 70 years
- •4.Liver biopsy ââ?¬â??if Feasible
- •5.Model for End-Stage Liver Disease (MELD) ââ?°Â¥ 20 and Maddrey DF ââ?°Â¥ 32
- •Donor evaluation
- •The subjects will be screened for
- •1. Routine laboratory tests (CBC; LFT; KFT; PT; INR)
- •2. Fasting blood sugar
- •3. Lipid profile
- •5. Anti-HCV
- •6. HIV 1 & 2
- •8. Stool routine and microscopy stool ova & cysts.
- •9. Stool culture
- •10. Clostridium difficile toxin
- •11. Helicobacter pylori stool antigen
- •12. Cryptosporidium & Isospora (acid fast stain)
排除标准
- •1.UGI Bleed within last one month
- •2.More then 3 organ failure requiring support
- •3.Mechanically ventilated patient , (patients requiring ICU/ HDU care) (On inotropic support)
- •4.Uncontrolled sepsis, DIC
- •5.Gut paralysis
- •6.Active hepatic or extra hepatic malignancy
- •7.Renal failure creatinine > 2.5
- •8.DF >120
- •9.MELD >35
- •10.Prior SBP/active SBP
- •11.Intestinal conditions like IBD, SIBO
- •Exclusion criteria for Donor
- •1.Antibiotic usage within 3 months of enrollment
- •2.Gastroenteritis within last 2 months
- •4.Diabetes mellitus
- •5.Inflammatory bowel disease
- •6.Any Malignancy
- •7.Chronic Kidney disease, Coronary artery disease
- •8.Cerebrovascular accident or chronic obstructive pulmonary disease
- •9.HBsAg, Anti HCV, HIV seropositivity
- •10.Transaminitis, dyslipidemia
- •11.Ova or cyst in stool, C. difficile toxin Positive
- •12.Chronic alcohol intake
- •13.Active substance abuse
研究者
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