CTRI/2023/02/050008招募中未知
Effect of Fecal Microbiota Transplantation (FMT) in patients with Minimal hepatic encephalopathy: An Open label 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.Age =18 years - 60 years
- •2.Cirrhosis (diagnosed based on biopsy, radiology, fibroscan or imaging evidence of portal hypertension)
- •3.Willing and able to comply with the FMT regimen and all other study requirements
- •4.The patient or guardian can provide written informed consent to participate in the study
排除标准
- •1.Cirrhosis with Overt HE
- •2.Pregnant or breastfeeding. Women of childbearing potential will be screened with beta-human chorionic gonadotropin (hCG).
- •3.Those receiving immunosuppression therapy
- •4.People living with HIV (PLHIV)
- •5.History of spontaneous bacterial peritonitis
- •6.Model for End-stage Liver disease score >18
- •7.Low protein ( <1.5g) ascites
- •8.Medical conditions that require prolonged or frequent use of systemic acyclovir or famciclovir (e.g., for recurrent herpes virus infections, etc). Prolonged use means episodic treatment with these agents for 10 days every 3 months or chronic suppressive therapy.
- •9.Acute variceal bleeding within last 4 weeks
- •10.Patients with acute on chronic liver failure (ACLF)
- •11.Patients with hepatocellular carcinoma (HCC)
- •12.Patients with a spontaneous portosystemic shunt (as diagnosed on CT scan)
- •13.Patients with alcohol consumption of more than 30 gm of ethanol or abusing illicit drugs within last 1 month.
- •14.Medical conditions, requiring potentially hepatotoxic drugs (e.g. dapsone, erythromycin, fluconazole, ketoconazole, rifampin, anti-tuberculosis regimens, others) or nephrotoxic drugs (e.g., frequent NSAIDs, aminoglycosides, amphotericin B, foscarnet).
- •15.Patients on warfarin or other anticoagulants for 30 days prior to screening or if expected during the present study.
- •16.Other concurrent medical conditions likely to preclude compliance with the schedule of evaluations in the protocol or likely to confound the efficacy or safety observations of the study (e.g., concurrent malignancies, history of unstable angina, repeated myocardial infarction or congestive heart failure, renal insufficiency, uncontrolled asthma or diabetes, unstable thyroid disease or other significant hormonal conditions, uncontrolled seizure disorders, severe psychiatric disorders, active tuberculosis under current treatment, etc)
- •17.Patient on antibiotics
- •18.Patient on Renal replacement therapy
- •19.Patients with a history of surgery within the last 3 months
- •20.Patients with an active autoimmune liver disease requiring treatment with steroids and immunomodulators (we should not exclude these patients)
- •21.Post TIPSS
研究者
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