CTRI/2022/10/046773招募中未知
Fecal Microbiota Transplantation (FMT) in Autoimmune Liver Diseases with incomplete response to standard therapy: 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 greater than equal to 18 years
- •2.AIH patients with insufficient response to treatment
- •3.AIH patients with treatment non-response (non-response to either first line immunosuppressants eg steroids, budesonide, azathioprine or non-response to subsequent second line immunosuppressants eg MMF, tacrolimus)
- •4.Patients with AIH, PSC, PBC or overlap syndrome (AIH-PBC, AIH-PSC)
- •5.Willing and able to comply with the FMT regimen and all other study requirements
- •6.The patient or guardian can provide written informed consent to participate in the study
排除标准
- •1.Patients with active infection (Bacterial/Fungal)
- •2.Pregnant or breastfeeding. Women of childbearing potential will be screened with beta-human chorionic gonadotropin (ß-hCG).
- •3.Those with co-existent etiologies for chronic liver disease, including hepatitis C virus (HCV), HBV, alcoholic liver disease, NAFLD and Wilson disease
- •4.People living with HIV (PLHIV)
- •5.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.
- •6.History of acute decompensation of chronic liver disease (defined as jaundice, ascites, variceal bleeding, hepatic encephalopathy, or spontaneous bacterial peritonitis)
- •7.Patients with acute on chronic liver failure (ACLF)
- •8.Patients with hepatocellular carcinoma (HCC)
- •9.Patients with daily alcohol consumption of more than 30 gm of ethanol or abusing illicit drugs
- •10.Medical conditions which require the use of 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).
- •11.Patients on warfarin or other anticoagulants for 30 days prior to screening or if expected during the present study.
- •12.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
- •13.MELD >22
研究者
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