NCT03143517已完成不适用
CALFE Stool Sample Collection Protocol
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 13
- 主要终点
- Calprotectin Stool Collection
研究概览
简要总结
The primary objective is to obtain stool samples from subjects diagnosed with , and displaying signs and/or symptoms of IBD and/or IBS will be evaluated in this study. Eligible subjects require a diagnostic colonoscopy with possible biopsy and clinical evaluation.
详细描述
Stools will be collected and tested, at a later date, in a clinical performance study with an investigational Calprotectin assay. This study will be coordinated by the Sponsor.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is of either gender and ≥ 4 years of age.
- •Subject is showing signs and symptoms of IBD and/or IBS.
- •Diagnosis of IBD, IBS or other gastrointestinal disorder is performed by colonoscopy.
- •Subject or authorized legal representative is willing and able to sign the IRB approved Informed Consent form or able to provide Informed Consent in accordance with 21 CFR 50 CFR 50 Subpart B.
- •Subject is able to understand and follow study sample collection procedure.
排除标准
- •Subject has undergone a surgical resection or diversion procedure.
- •Subject is currently taking NSAIDS (non-steroidal anti-inflammatory drugs, i.e. ibuprofen, Advil, Motrin, Naproxen, Aleve including regular dose and low dose aspirin) within 7 days of colonoscopy and sample collection.
- •Subject who has taken immunomodulators or biologic therapies within the previous 6 months of colonoscopy and sample collection.
- •Subject who is currently pregnant or lactating.
- •Subject is unable or unwilling to follow informed consent.
- •Inability or unwilling to perform required study procedures.
结局指标
主要结局
Calprotectin Stool Collection
时间窗: Through Study Completion, an average of 1 year
In vitro diagnostic (IVD) device performance
次要结局
未报告次要终点
研究者
研究点 (13)
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