ALPCO/Calprotectin CLIA Assay: Expected Values of Calprotectin in Healthy Subjects

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: t
View:

• 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)

Locations
United States
New Hampshire
ALPCO
RECRUITING
Salem
Contact Information
Primary
Yomi Ojutalayo
clinops@alpco.com
800-592-5726
Backup
Jim Richard
regulatory@alpco.com
800-592-5726
Time Frame
Start Date: 2025-07-07
Estimated Completion Date: 2025-10
Participants
Target number of participants: 120
Treatments
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.
Sponsors
Leads: American Laboratory Products Company

This content was sourced from clinicaltrials.gov