Recruiting

Calprotectin

Sponsor:

American Laboratory Products Company

Code:

NCT06810518

Conditions

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

Inflammatory Bowel Syndrome

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Accepted

Interventions

ALPCO Calprotectin CLIA

Study Details

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.

Conditions

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

Inflammatory Bowel Syndrome

Study ID

NCT06810518

Start date

Mar 25, 2025

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

220 participants

Anticipated

Interventions and Outcome Measures

Arms

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

ALPCO Calprotectin CLIA

Measurement of calprotectin in feces

Primary outcome measure

  • In vitro diagnostic value of Calprotectin [ Time Frame: Through study completion, up to 52 weeks. ]

Central Contacts and Locations

Central contacts

Yomi Ojutalayo

800-592-5726clinops@alpco.com

Jim Richard

800-592-5726regulatory@alpco.com

Locations

Med-Care Research Corp

Recruiting

Miami, Florida, United States, 33125

Gastro Intestinal Research Institute of Northern Ohio,

Recruiting

Westlake, Ohio, United States, 44145

More Information

Sponsor

American Laboratory Products Company

Last update posted

Apr 28, 2026

Last verified

Apr, 2026

Keywords

  • calprotectin
  • IBD
  • IBS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by American Laboratory Products Company on 2026-04-28.