RECRUITING

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

Conditions

Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)Inflammatory Bowel Syndrome calprotectin IBD IBS

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03-25

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06810518

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Yomi Ojutalayo

CONTACT

800-592-5726

clinops@alpco.com

Jim Richard

CONTACT

800-592-5726

regulatory@alpco.com

Study Locations (Sites)

Med-Care Research Corp

Miami, Florida, 33125

United States

ALPCO

Salem, New Hampshire, 03079

United States

Gastro Intestinal Research Institute of Northern Ohio,

West Lake, Ohio, 44145

United States

Collaborators and Investigators

Sponsor: American Laboratory Products Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-25

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2025-03-25

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

calprotectin
IBD
IBS

Additional Relevant MeSH Terms

Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)
Inflammatory Bowel Syndrome