ALPCO/Calprotectin CLIA Assay: Expected Values of Calprotectin in Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Establish the Expected Reference Range for Fecal Calprotectin in Healthy Adults
研究概览
简要总结
This study is evaluating the levels of calprotectin, a protein found in stool, in healthy adults. Calprotectin is a marker of inflammation in the intestines and can help doctors tell the difference between inflammatory bowel diseases (IBD), like Crohn's disease or ulcerative colitis, and non-inflammatory conditions like irritable bowel syndrome (IBS).
In this study, healthy volunteers aged 22 and older will collect a stool sample at home using a simple kit and mail it to the study site. The samples will be tested using a new laboratory method called the ALPCO Calprotectin CLIA assay. The goal is to confirm what level of calprotectin is considered "normal" in people without intestinal disease.
Participation involves just one stool sample, and there are no medical procedures. Volunteers will be compensated for their time. The study will help improve how doctors interpret calprotectin test results in clinical settings.
详细描述
This study is designed to evaluate the expected (normal) values of calprotectin in the stool of healthy adults using the ALPCO Calprotectin CLIA assay, an investigational in vitro diagnostic test. Calprotectin is a protein released during intestinal inflammation and is commonly used as a non-invasive biomarker to assess gastrointestinal diseases. Elevated levels of fecal calprotectin can indicate active inflammation, particularly in patients with inflammatory bowel disease (IBD), such as Crohn's disease or ulcerative colitis. Conversely, low levels are typically associated with non-inflammatory conditions like irritable bowel syndrome (IBS).
The purpose of this study is to establish baseline (expected) calprotectin levels in individuals who do not have symptoms of IBD, IBS, or other chronic intestinal conditions. These expected values are essential to validate the performance of the ALPCO Calprotectin CLIA assay and to guide its use in differentiating inflammatory and non-inflammatory gastrointestinal conditions in clinical practice.
Approximately 120-150 healthy adult volunteers, aged 22 and older, will be enrolled at 1-2 U.S. clinical sites. Eligible participants will not have any history of chronic intestinal disorders, cancer, recent use of NSAIDs or GI medications, or active gastrointestinal symptoms. After providing informed consent, each participant will collect a stool sample at home using a provided sample collection kit. The sample will be returned to ALPCO by mail or delivery, where it will be analyzed in a laboratory using the study assay.
Stool samples will be processed, stored, and tested according to standardized procedures. The results of this study will be used to determine the reference cut-off value for a healthy population (currently hypothesized at 50 µg/g) and to support the performance claims of the ALPCO Calprotectin CLIA assay in future regulatory submissions.
Participants will be compensated for their participation. There is no direct medical benefit to participants, and the test results will not be shared with them. All samples and data will be handled confidentially, in accordance with Good Clinical Practice (GCP), U.S. FDA regulations, and HIPAA.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Adults aged ≥22 years
- •No abdominal symptoms and no history of inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), or other chronic intestinal disorders
- •May have undergone colonoscopy with negative findings within the past month or never undergone colonoscopy
- •Able and willing to provide a stool sample according to the collection protocol
- •Able to understand the study and sign the informed consent form (ICF)
排除标准
- •Unable or unwilling to provide a stool sample
- •Known active intestinal cancer or history of intestinal cancer with abnormal clinical findings
- •Currently receiving chemotherapy or systemic immunosuppressive medications
- •Use of proton pump inhibitors (PPIs) or H2-receptor antagonists within the last 2 weeks
- •Use of NSAIDs (including aspirin) for 7 or more days in the past 2 weeks
- •Presence of gastrointestinal symptoms such as abdominal pain, diarrhea, altered appetite, weight loss, or anemia
- •Samples collected not following protocol requirements
- •Any other condition that, in the opinion of the investigator, may interfere with study participation or data validity
研究组 & 干预措施
Healthy Adult Volunteers
This group will include approximately 120 to 150 asymptomatic, healthy adults aged 22 years or older. Participants must have no history of inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), gastrointestinal cancer, or chronic intestinal disorders. They must not be taking immunosuppressive therapy, proton pump inhibitors, H2 blockers, or NSAIDs as outlined in the exclusion criteria.
Participants will collect a single stool sample at home using a provided kit and ship it to the sponsor site (ALPCO) for laboratory analysis. The stool samples will be tested using the ALPCO Calprotectin CLIA assay, a chemiluminescent immunoassay designed to measure fecal calprotectin levels. This group serves to establish reference (expected) calprotectin values in healthy individuals, which will support assay validation and performance claims.
干预措施: ALPCO Calprotectin CLIA (Device)
结局指标
主要结局
Establish the Expected Reference Range for Fecal Calprotectin in Healthy Adults
时间窗: Within 2 months of sample collection
Determine the distribution and expected (normal) reference range of fecal calprotectin concentrations in healthy adults using the ALPCO Calprotectin CLIA assay. The outcome will confirm whether the predefined clinical cut-off value of \<50 µg/g accurately reflects a non-inflammatory baseline in an asymptomatic population.
次要结局
未报告次要终点