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

NCT07089420 | Completed FDA Device

• 1 other identifier: CPSP-2025-011
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Crohn Disease (CD); UC - Ulcerative Colitis; IBD (Inflammatory Bowel Disease); IBS - Irritable Bowel Syndrome

Keywords

Calprotectin; IBD; IBS

Outcome Measures

Primary Outcomes (1)

• Establish the Expected Reference Range for Fecal Calprotectin in Healthy Adults

  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.

  Within 2 months of sample collection

Study Arms (1)

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.

Device: ALPCO Calprotectin CLIA

Interventions

ALPCO Calprotectin CLIA DEVICE

Measurement of calprotectin in feces

Healthy Adult Volunteers

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will enroll approximately 120 to 150 healthy adult volunteers, aged 22 years or older, from the general U.S. population. Participants must be asymptomatic with no history of inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), gastrointestinal cancer, or other chronic intestinal conditions. Subjects must not be on immunosuppressive therapy, PPIs, H2 blockers, or regular NSAID use prior to sample collection. The goal is to represent a normal, healthy population to establish baseline calprotectin levels using the ALPCO Calprotectin CLIA assay.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• American Laboratory Products Company: lead

Study Sites (1)

ALPCO

Salem, New Hampshire, 03079, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Irritable Bowel Syndrome; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Colitis

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 28, 2025
• Study Start: July 7, 2025
• Primary Completion: April 15, 2026
• Study Completion: April 15, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)