Measuring Calprotectin Levels in Stool for Diagnosing Inflammatory Bowel Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion criteria:

* Male or female, ≥22 years of age (adults)
* Subjects with suspected inflammatory bowel disease or irritable bowel syndrome presenting one or more of the following symptoms: abdominal pain, diarrhea, altered appetite, anemia, or unexpected weight loss. Not all symptoms are required; clinical presentation must support suspicion of inflammatory bowel disease or irritable bowel syndrome in the investigator's opinion.
* Able to provide a sample either within 14 days before beginning bowel preparation for the scheduled colonoscopy, or between 3 and 14 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)
* Subjects receiving chemotherapy or systemic immunosuppressive drugs without completing an 8-week washout period IBD patients who have previously diagnosed with 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 surgical resection or diversion procedure.
* Current or active upper gastrointestinal disease (e.g., esophagitis, gastritis, GERD, or acid reflux) with ongoing symptoms or requiring active treatment.
* Use of proton pump inhibitors (PPIs) or H2-receptor antagonists within the 2 weeks prior to providing the stool sample.
* Use of NSAIDs, including aspirin, on seven or more days within the 14 days prior to sample collection.
* Samples are not collected according to sampling protocol.
* Any condition that in the opinion of the investigator should preclude participation in the study.

Where it's running

• Med-Care Research Corp
  Miami, Florida, United States Recruiting
• Gastro Intestinal Research Institute of Northern Ohio,
  Westlake, Ohio, United States Recruiting
• Alpco
  Salem, New Hampshire, United States Not yet recruiting

Study contacts

• Study coordinator: Yomi Ojutalayo
• Email: clinops@alpco.com
• Phone: 800-592-5726

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.