NCT06206707招募中不适用
Faecal Microbiota Transplantation for Immune Checkpoint Inhibitor-mediated Diarrhea/Colitis: a Randomised, Double-blind Pilot Efficacy and Safety Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Clinical remission of immune-mediated diarrhea
研究概览
简要总结
The goal of this clinical trial is to determine the outcome of patients with immune checkpoint inhibitor-mediated diarrhea/colitis (IMC) treated with faecal microbiota transplantation (FMT) in a randomised, placebo-controlled trial.
The aim of the present study is to assess the feasibility, pilot efficacy, and safety of FMT for patients with IMC.
Participants will be treated two times with capsule FMT or placebo capsules in a 1:1 ratio. The intervention treatment will be an add-on to the patients' standard treatment for IMC.
Researchers will compare the FMT-treated group to the placebo-treated group to see if FMT promotes remission of IMC.
详细描述
As above
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or above.
- •Histologically proven diagnosis of malignant melanoma and/or kidney cancer.
- •Treatment with any immune checkpoint inhibitor (Nivolumab, Pembrolizumab, Cemiplimab, Atezolizumab, Durvalumab, Avelumab, Ipilimumab), alone or in combination, within the last 8 weeks.
- •Grade 2 or higher CTCAE diarrhea, of which at least 3 stools are Bristol chart score 6-
- •Negative PCR for enteric pathogens including C. difficile, after the onset of diarrhea.
- •Signed written informed consent.
排除标准
- •Diagnosed bacterial infection requiring antibiotic treatment at inclusion.
- •Pregnancy or breastfeeding. Pregnancy ruled out by male sex, postmenopausal women or a negative choriogonadotropin (hCG) urine test.
- •Primary diarrheal disease pre-existing to the immune checkpoint inhibitor treatment, including inflammatory bowel disease.
- •Unable to ingest capsules.
- •Unable to understand written or oral patient information.
结局指标
主要结局
Clinical remission of immune-mediated diarrhea
时间窗: At 42 days after intervention treatment
Number of patients with steroid-free resolution of diarrhea, defined as \< 3 liquid stools (Bristol \<6) per 24 hours during day 40 and 41 after the last intervention treatment.
次要结局
- Remission of diarrhea defined by CTCAE(At 42 days after intervention treatment)
- Faecal-calprotectin(Up to 6 weeks after intervention treatment)
- Endoscopic remission(Up to 6 weeks after intervention treatment)
- Remission of colitis defined by CTCAE(At 42 days after intervention treatment)
- Number of days until CTCAE diarrhea grade 1(Up to 12 weeks after intervention treatment)
- Gut mucosa-associated microbiome(Up to 6 weeks after intervention treatment)
- Resumption of immune checkpoint inhibitor therapy(Up to 12 weeks after intervention treatment)
- Therapy response of FMT(Up to 12 weeks after intervention treatment)
- Faecal microbiota composition(Up to 6 weeks after intervention treatment)
- Endoscopic response(Up to 6 weeks after intervention treatment)
- Number of days until resolution of diarrhea(Up to 12 weeks after intervention treatment)
- Incidence of fecal microbiota transplantation (FMT)-related adverse events(At 42 days after intervention treatment)
- Incidence of fecal microbiota transplantation (FMT)-related serious adverse events(At 12 weeks after intervention treatment)
- Hospitalisation(Up to 12 weeks after intervention treatment)
- Accumulated steroid dose(Up to 12 weeks after intervention treatment)
- Blood immunological parameters(Up to 6 weeks after intervention treatment)
- Mortality(Up to 12 weeks after intervention treatment)
- Response to immune checkpoint inhibitor therapy(Up to 12 weeks after intervention treatment)
- Patient and physician perceptions of FMT treatment(At 42 days after intervention treatment)
- Health-related quality of life(At 42 days after intervention treatment)
- Colectomy(Up to 12 weeks after intervention treatment)
研究者
研究点 (2)
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