ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool

Launched by AMERICAN LABORATORY PRODUCTS COMPANY · Jan 31, 2025

Keywords

ClinConnect Summary

The ALPCO Calprotectin CLIA trial is studying a test that measures a protein called calprotectin in stool samples. This test can help doctors understand if someone has Inflammatory Bowel Disease (IBD), such as Crohn's Disease or Ulcerative Colitis, or if their symptoms are due to Irritable Bowel Syndrome (IBS). By measuring calprotectin levels, the test may help differentiate between these conditions, providing valuable information for diagnosis and treatment.

To be eligible for this study, participants must be adults aged 22 and older who have symptoms like abdominal pain, diarrhea, or weight loss, and are suspected of having IBD or IBS. Participants will need to provide a stool sample within a specific time frame before or after a colonoscopy. If you decide to join, you will receive detailed information about the study and what is expected from you, as well as any potential risks involved. This trial is currently recruiting participants of all genders, and it's an important step toward improving diagnosis and care for those with bowel conditions.

Gender

ALL

Eligibility 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.