ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool
1 other identifier
observational
220
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2025
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2025
CompletedFirst Posted
Study publicly available on registry
February 5, 2025
CompletedStudy Start
First participant enrolled
March 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
April 28, 2026
April 1, 2026
1.8 years
January 31, 2025
April 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
In vitro diagnostic value of Calprotectin
Value of calprotectin measurement using the ALPCO Calprotectin CLIA on the chemiluminescent automated KleeYa instrument.
Through study completion, up to 52 weeks.
Study Arms (4)
IBD
Adult subjects diagnosed with IBD via endoscopy and histological findings.
IBS
Adult subjects with IBS as per the Rome IV criteria.
Other GI Disorders
Adult subjects with gastrointestinal disorders not meeting the Rome IV criteria or IBD diagnosis.
Healthy Subjects
Adult subjects without any gastrointestinal complaints.
Interventions
Measurement of calprotectin in feces
Eligibility Criteria
Individuals that presents with symptoms of IBS/IBD and otherwise healthy subjects
You may qualify if:
- Male or female, ≥22 years of age (adults)
- 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 sample according to the sampling protocol within 72-24 hours prior to the scheduled diagnostic endoscopy or 3-30 days after the colonoscopy.
- Able to understand the study and the tasks required and sign the ICF
You may not qualify if:
- Unable or unwilling to provide a stool specimen
- Known active intestinal cancer or in remission with abnormal levels (per physician assessment)
- Known active intestinal infection or history of treated intestinal infection with persistent abnormal levels (per physician assessment)
- IBD patients receiving chemotherapy or systemic immunosuppressive drugs without completing an 8-week washout period
- IBD patients who have previously diagnosed IBD managed with immunomodulators, 5-ASA or biologic therapies without completing an 8-week washout period for biologics and immunomodulators or 4 weeks for 5-ASA
- IBD patients who have previously been diagnosed with IBD and have undergone a surgical resection or diversion procedure.
- Known upper Gl disease such as esophagitis or gastritis that might influence the study test's ability to detect intestinal inflammatory disease
- Have taken NSAIDS (including aspirin) on 7 or more days during the 2 weeks before providing the sample
- Samples are not collected according to sampling protocol.
- Any condition that in the opinion of the investigator should preclude participation in the study.
- Using an IRB approved consent form, all study participants will be advised of study requirements and potential risks associated with study participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Med-Care Research Corp
Miami, Florida, 33125, United States
ALPCO
Salem, New Hampshire, 03079, United States
Gastro Intestinal Research Institute of Northern Ohio,
Westlake, Ohio, 44145, United States
Biospecimen
Stool
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2025
First Posted
February 5, 2025
Study Start
March 25, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
April 28, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share