NCT03082287已完成不适用
ALPCO Calprotectin ELISA - Measurement of Calprotectin Levels in Human Stool
American Laboratory Products Company1 个研究点 分布在 1 个国家目标入组 424 人开始时间: 2017年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 424
- 试验地点
- 1
- 主要终点
- In vitro diagnostic value of Calprotectin
研究概览
简要总结
The ALPCO Calprotectin ELISA is an in vitro diagnostic test intended to quantitatively measure concentrations of fecal calprotectin in human stool samples. Calprotectin is a protein biomarker of mucosal inflammation. Measurement of calprotectin can aid in the diagnosis of Inflammatory Bowel Diseases (IBD), specifically Crohn's Disease (CD) and Ulcerative Colitis (UC), as well as aid in the differentiation of IBD from Irritable Bowel Syndrome (IBS) when used in conjunction with other diagnostic testing and the total clinical picture. This study will estimate the predictive values of a negative (NPV) and positive (PPV) test by utilizing the assay outcomes of the ALPCO Calprotectin ELISA.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria (IBD or IBS subjects):
- •>18 years of age
- •Patient must present with signs and symptoms of IBS or IBD
- •Patient must be scheduled for a colonoscopy
- •All results of the colonoscopy including histology must be provided to study site and sponsor.
- •Medical Chart review may be required to confirm diagnosis of IBS or IBD
- •Patient must not have taken NSAIDs for at least 2 weeks prior to participating in the study. Patients may be advised of the study and if report taking NSAIDS may be enrolled in the study after the patient has stopped use of NSAIDS for a minimum of 2 weeks.
- •For normal patient population - study participants must present with no signs or symptoms of IBS or IBD, must not have taken NSAIDs for at least a period of 2 weeks and must be willing to provide a stool sample.
- •Sample must be collected at least 2-3 days prior to colonoscopy
- •Inclusion Criteria (normal subjects):
- •Male or female, ≥18 years of age.
- •No abdominal complaints and no history of IBS, IBD, or other chronic intestinal disorder, confirmed by medical history and physical examination at enrollment.
- •May have undergone colonoscopy with negative findings within the past 1 month or may have no recent colonoscopy, but scheduled for routine screening colonoscopy.
- •Able to understand the study and the task required, and sign the ICF.
排除标准
- •Exclusion Criteria (IBD or IBS Subjects):
- •patient under the age of 18
- •Patient taking NSAIDs
- •Patients not presenting with signs or symptoms of IBS or IBD with the exception of 100 normal patients to be included in the study. Fifty (50) presenting for routine colonoscopy and 50 patients presenting with no disease symptoms and not scheduled for a colonoscopy.
- •Patients not scheduled to have an colonoscopy unless enrolled in the study as normal population
- •Exclusion Criteria (normal subjects):
- •Unable or unwilling to provide a stool specimen.
- •Have taken protein pump inhibitors (PPIs) or H2-receptor antagonists for control of upper GI disease within the previous 2 weeks.
- •Have taken NSAIDs (including aspirin) on within 2 weeks of study enrollment.
结局指标
主要结局
In vitro diagnostic value of Calprotectin
时间窗: Through study completion, up to 52 weeks.
Value of calprotectin measurement in the ELISA
次要结局
未报告次要终点
研究者
研究点 (1)
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