ACTRN12623000492651尚未招募Unknown
Observation of Faecal Microbiota Transplantation Use for Restoration of Gut Microbiota in Gastrointestinal Disorders in the Real-World Setting (The REAL-BIOME (Real-world Microbiome) Study).A Phase IV, Real-World, Prospective, Open-Label, Observational Study.
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- BiomeBank
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1) Aged 18 years or older.
- •2) Confirmed diagnosis of ulcerative colitis, Crohn's disease, irritable bowel syndrome, immune checkpoint inhibitor-induced enterocolitis, or functional constipation.
- •3) Prescribed BiomeBank FMT by treating specialist physician for their gastrointestinal disorder. The prescribing physician must have received approval from the TGA to treat the patient with FMT off-label via the Special Access Scheme. This must occur before patient is eligible for the study, but is not a part of the study process.
- •4) Has not received FMT in 8 weeks prior to study entry.
排除标准
- •1) Anaphylactic food allergy.
- •2) Pregnancy.
研究者
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