2023-507790-18-00招募中2 期
Encapsulated Fecal Microbiota Transfer to Treat Immune Activation in Patients with Cirrhosis and Ascites (TransImmune) – A randomized, double-blind, placebo-controlled phase IIa clinical pilot study
Universitaetsklinikum Aachen AöR1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年8月8日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The occurrence of serious adverse event (SAE) up to the end of the study (EOS).
研究概览
简要总结
To evaluate the safety of FMT capsules for the treatment of immune activation in patients with cirrhosis and ascites.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Subject has cirrhosis of any etiology based on clinical standard criteria, imaging findings, and/or histology.
- •Subject is diagnosed with ascites and has undergone paracentesis or diagnostic ascitic tap within the last 30 days prior to study inclusion.
- •Subject age is between 18 and 70 years at the time of study inclusion.
- •Subject is able to swallow the Investigational Medicinal Product (IMP) Fecal Microbiota Transfer capsules or placebo.
- •Subject is mentally and physically able to understand the significance and scope of the study and to comply with the study protocol.
- •A written informed consent form has been signed prior to participation in the study.
排除标准
- •Subject has acute-on-chronic liver failure (ACLF) grade 2 or higher according to the EASL-CLIF Consortium definition.
- •Subject is not willing to take adequately safe contraceptive measures.
- •Study participation is, at the discretion of the investigator, an unacceptable risk due to pre-existing or concomitant disease or due to the patient's general underlying condition.
- •There is a current or past medically relevant disease or treatment that could influence the evaluation of the study.
- •Subject has received an investigational drug in another study within the last 30 days before study inclusion.
- •Concurrent participation in another clinical intervention study.
- •Subject is institutionalized due to an official or court order.
- •Subject is in a dependent relationship or employment relationship with the sponsor or investigator.
- •Subject has Model for End-Stage Liver Disease (MELD) score >
- •Subject has received systemic antibiotics within 7 days prior to study inclusion, except for stable doses of norfloxacin or rifaximin.
- •Subject has active malignancy or history of malignancy, which was not curatively treated (excluding non-melanoma skin cancer).
- •Subject receives treatment with immunomodulatory drugs, including corticosteroids, thiopurines, calcineurin inhibitors, and mycophenolate currently or within 90 days prior to study inclusion.
- •Subject has a history of hypersensitivity or allergies to the investigational capsule coating substances or to any compound of INTESTIFIX 001 or placebo.
- •Subject has an expected lack of compliance.
- •Subject has a life expectancy of less than six months.
- •Subject is pregnant or breastfeeding.
结局指标
主要结局
The occurrence of serious adverse event (SAE) up to the end of the study (EOS).
The occurrence of serious adverse event (SAE) up to the end of the study (EOS).
The occurrence and its severity of treatment-emergent adverse events (TEAE) and adverse events (AE).
The occurrence and its severity of treatment-emergent adverse events (TEAE) and adverse events (AE).
次要结局
- Systemic inflammation: Differences in white blood cell count, C-reactive protein, procalcitonin, and IL-6 between baseline (day 0) and V3 (day 7±2), V4 (day 28±3), and EOS (day 90+14).
- Gut inflammation: Differences in faecal calprotectin between baseline (day 0) and V3 (day 7±2), V4 (day 28±3), and EOS (day 90+14).
- Organ dysfunction: Differences in Child-Pugh score, Model of End Stage Liver Disease (MELD) score, Chronic Liver Failure-Sequential Organ Failure Assessment (CLIF-SOFA / CLIF-C OF) score between baseline (day 0) and V3 (day 7±2), V4 (day 28±3), and EOS (day 90+14).
- Quality of life: Differences in EQ-5D-5L and CLDQ score between baseline (day 0) and EOS (day 90+14.
- Antibiotic-free days: Number of days without antibiotic use (except for oral use of norfloxacin or rifaximin) between baseline (day 0) and EOS (day 90+14).
研究者
Univ.-Prof. Dr. med. habil. Tony Bruns
Scientific
Universitaetsklinikum Aachen AöR
研究点 (1)
Loading locations...
相似试验
招募中
2 期
Fecal Microbiota Transplantation to RESCUE patients with unresectable Hcc progressors to first line therapy with AtezolizUmaB and Bevacizumab (RESCUE-HUB)2023-510504-45-00Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico15
招募中
2 期
Fecal Microbiota Transplantation to RESCUE Patients With Unresectable Hcc Progressors to First Line Therapy With AtezolizUmaB and BevacizumabNCT07276100IRCCS Azienda Ospedaliero-Universitaria di Bologna15
招募中
2 期
Fecal Microbiota Transfer in Liver Cancer to Overcome Resistance to Atezolizumab/Bevacizumab – A randomized, placebo-controlled, double-blind Phase II trial (FLORA)Hepatocellular carcinoma2023-506887-15-00Universitaetsklinikum Heidelberg AöR48
招募中
2 期
Fecal microbiota transfer for the secondary prevention of recurrent urinary tract infections in premenopausal women: a phase II trial (FEMITRANS)2025-520452-28-00Goethe University Frankfurt24
招募中
3 期
Fecal microbiota transplantation for primary sclerosing cholangitis - randomized study versus sham transplantation (FMT-SCLER).Primary Sclerosing Cholangitis2023-505469-95-00Assistance Publique Hopitaux De Paris72