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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

22 Years - N/A

Healthy Volunteers

Accepted

Interventions

• ALPCO Calprotectin CLIA — DEVICE
  Measurement of calprotectin in feces

Study Details

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.

Key Dates

Start date

Mar 25, 2025

Status verified

Apr 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

220 participants (estimated)

Arms

• Arm: IBD
  Adult subjects diagnosed with IBD via endoscopy and histological findings.
• Arm: IBS
  Adult subjects with IBS as per the Rome IV criteria.
• Arm: Other GI Disorders
  Adult subjects with gastrointestinal disorders not meeting the Rome IV criteria or IBD diagnosis.
• Arm: Healthy Subjects
  Adult subjects without any gastrointestinal complaints.

Primary Outcome Measure

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

Central Contacts

• Yomi Ojutalayo
  800-592-5726
  [email protected]
• Jim Richard
  800-592-5726
  [email protected]

Locations (3)

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