Actively Recruiting
ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool
Led by American Laboratory Products Company · Updated on 2026-04-28
220
Participants Needed
3
Research Sites
92 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The ALPCO Calprotectin CLIA 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. The goal of the study is to generate data to support positive and negative predictive value of the ALPCO Calprotectin assay in patients with signs and symptoms of IBS or IBD.
CONDITIONS
Official Title
ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, 2 years of age or older
- Suspected inflammatory bowel disease or irritable bowel syndrome with symptoms such as abdominal pain, diarrhea, altered appetite, weight loss, or anemia
- Able to provide a stool sample according to the sampling protocol within 72 to 24 hours prior to scheduled diagnostic endoscopy or 3 to 30 days after colonoscopy
- Able to understand the study and tasks and willing to sign informed consent form
You will not qualify if you...
- Unable or unwilling to provide a stool specimen
- Known active intestinal cancer or in remission with abnormal levels as assessed by physician
- Known active intestinal infection or history of treated infection with persistent abnormal levels as assessed by physician
- IBD patients receiving chemotherapy or systemic immunosuppressive drugs without completing an 8-week washout period
- IBD patients previously treated with immunomodulators, 5-ASA, or biologics without completing required washout periods (8 weeks for biologics and immunomodulators, 4 weeks for 5-ASA)
- IBD patients with previous surgical resection or diversion procedure
- Known upper gastrointestinal diseases such as esophagitis or gastritis that might affect test accuracy
- Use of NSAIDs (including aspirin) on 7 or more days during the 2 weeks before providing the sample
- Samples not collected according to sampling protocol
- Any condition that investigator believes should prevent participation in the study
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Med-Care Research Corp
Miami, Florida, United States, 33125
Actively Recruiting
2
ALPCO
Salem, New Hampshire, United States, 03079
Not Yet Recruiting
3
Gastro Intestinal Research Institute of Northern Ohio,
Westlake, Ohio, United States, 44145
Actively Recruiting
Research Team
Y
Yomi Ojutalayo
CONTACT
J
Jim Richard
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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