Measuring Calprotectin Levels in Stool for Diagnosing Inflammatory Bowel Disease
ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool
This study is testing a new stool test to see if it can help doctors diagnose Inflammatory Bowel Diseases like Crohn's and Ulcerative Colitis more accurately.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 220 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | American Laboratory Products Company Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Miami, Florida and 2 other locations) |
| Trial ID | NCT06810518 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the ALPCO Calprotectin CLIA assay, which quantitatively measures calprotectin levels in human stool samples. Calprotectin is a protein biomarker that indicates mucosal inflammation, helping to diagnose Inflammatory Bowel Diseases (IBD) like Crohn's Disease and Ulcerative Colitis, and differentiate them from Irritable Bowel Syndrome (IBS). The study will compare the assay's sensitivity and specificity against gastroenterologist diagnoses, including colonoscopy results, to establish its predictive value. Participants will provide stool samples before or after diagnostic endoscopy to support the validation of the assay's cut-off values for clinical use.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22 and older with suspected inflammatory bowel disease or irritable bowel syndrome presenting specific gastrointestinal symptoms.
Not a fit: Patients with known active intestinal cancer, active infections, or those currently receiving certain immunosuppressive therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this assay could provide a non-invasive method for accurately diagnosing IBD and distinguishing it from IBS, leading to better patient management.
How similar studies have performed: Previous studies have shown promising results with calprotectin as a biomarker for IBD, indicating that this approach is supported by existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * 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 Exclusion criteria: * 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.
Where this trial is running
Miami, Florida and 2 other locations
- Med-Care Research Corp — Miami, Florida, United States (Recruiting)
- Alpco — Salem, New Hampshire, United States (Not_yet_recruiting)
- Gastro Intestinal Research Institute of Northern Ohio, — Westlake, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Yomi Ojutalayo
- Email: clinops@alpco.com
- Phone: 800-592-5726
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.