ACTRN12624000120572招募中Unknown
A Pilot Study of the Efficacy and Safety of Faecal Microbiota Transplant for the Treatment of Immune Checkpoint Inhibitor Colitis
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •18 years of age or older.
- •- Able to provide informed consent.
- •- Receipt of an immune checkpoint inhibitor agent (e.g. anti-CTLA-4, anti-PD-(L)1) as part of a treatment regimen for a solid cancer within 6 months of the onset of colitis symptoms. The ICI may be used as a single agent, or in combination with other ICIs, or with chemotherapy.
- •- Current diagnosis of immune-related diarrhoea and/or colitis characterized by grade 2 diarrhea as per CTCAE v5.0.
- •- Treatment including corticosteroid and biologic naive
排除标准
- •- Patients who have received either corticosteroid or immunosuppressive treatment for the current episode of ICI colitis
- •- Life-threatening food allergies, e.g. nut allergy
- •- Patients unable to provide informed consent
- •- Patients with a known diagnosis of inflammatory bowel disease
- •- Patients with a previous total colectomy
- •- Patients with an –ostomy (i.e. ileostomy or colostomy)
- •- Diagnosis of a thromboembolic event (deep vein thrombosis, pulmonary embolism, embolic stroke, myocardial infarction, or peripheral arterial insufficiency) within 3 months of enrollment.
- •- Diagnosis of concomitant infectious colitis (e.g. C. difficile or other bacterial source), unless the patient has finished an appropriate length of treatment with antibiotics as indicated for each diagnosis at the time of enrollment.
- •- Active pregnancy or breastfeeding.
研究者
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