ALPCO Calprotectin ELISA - Measurement of Calprotectin Levels in Human Stool

The ALPCO Calprotectin ELISA 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. This study will estimate the predictive values of a negative (NPV) and positive (PPV) test by utilizing the assay outcomes of the ALPCO Calprotectin ELISA.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome; Inflammatory Bowel Diseases
• Intervention / Treatment: Device: Fecal Calprotectin Level

• Study Type: Observational
• Enrollment (Actual): 424

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Salem, New Hampshire, United States, 03079
      • ALPCO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Individuals that presents with symptoms of IBS/IBD and otherwise healthy subjects

Description

Inclusion Criteria:

Inclusion Criteria (IBD or IBS subjects):

• >18 years of age
• Patient must present with signs and symptoms of IBS or IBD
• Patient must be scheduled for a colonoscopy
• All results of the colonoscopy including histology must be provided to study site and sponsor.
• Medical Chart review may be required to confirm diagnosis of IBS or IBD
• Patient must not have taken NSAIDs for at least 2 weeks prior to participating in the study. Patients may be advised of the study and if report taking NSAIDS may be enrolled in the study after the patient has stopped use of NSAIDS for a minimum of 2 weeks.
• For normal patient population - study participants must present with no signs or symptoms of IBS or IBD, must not have taken NSAIDs for at least a period of 2 weeks and must be willing to provide a stool sample.
• Sample must be collected at least 2-3 days prior to colonoscopy

Inclusion Criteria (normal subjects):

• Male or female, ≥18 years of age.
• No abdominal complaints and no history of IBS, IBD, or other chronic intestinal disorder, confirmed by medical history and physical examination at enrollment.
• May have undergone colonoscopy with negative findings within the past 1 month or may have no recent colonoscopy, but scheduled for routine screening colonoscopy.
• Able to understand the study and the task required, and sign the ICF.

Exclusion Criteria:

Exclusion Criteria (IBD or IBS Subjects):

• patient under the age of 18
• Patient taking NSAIDs
• Patients not presenting with signs or symptoms of IBS or IBD with the exception of 100 normal patients to be included in the study. Fifty (50) presenting for routine colonoscopy and 50 patients presenting with no disease symptoms and not scheduled for a colonoscopy.
• Patients not scheduled to have an colonoscopy unless enrolled in the study as normal population

Exclusion Criteria (normal subjects):

• Unable or unwilling to provide a stool specimen.
• Have taken protein pump inhibitors (PPIs) or H2-receptor antagonists for control of upper GI disease within the previous 2 weeks.
• Have taken NSAIDs (including aspirin) on within 2 weeks of study enrollment.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
IBD; Adult subjects diagnosed with IBD via endoscopy and histological findings.	Device: Fecal Calprotectin Level; Measurement of calprotectin in feces
IBS; Adult subjects with IBS as per the Rome IV criteria.	Device: Fecal Calprotectin Level; Measurement of calprotectin in feces
Other GI Disorders; Adult subjects with gastrointestinal disorders not meeting the Rome IV criteria or IBD diagnosis.	Device: Fecal Calprotectin Level; Measurement of calprotectin in feces
Healthy Subjects; Adult subjects without any gastrointestinal complaints.	Device: Fecal Calprotectin Level; Measurement of calprotectin in feces

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In vitro diagnostic value of Calprotectin	Value of calprotectin measurement in the ELISA	Through study completion, up to 52 weeks.

Collaborators and Investigators

• Sponsor: American Laboratory Products Company
• Collaborators: MDC Associates, LLC
• Investigators: Study Director: Fran White, MDC Associates

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2017
• Primary Completion (ACTUAL): October 25, 2019
• Study Completion (ACTUAL): October 25, 2019

Study Registration Dates

• First Submitted: March 6, 2017
• First Submitted That Met QC Criteria: March 13, 2017
• First Posted (ACTUAL): March 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 5, 2019
• Last Update Submitted That Met QC Criteria: November 4, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Irritable Bowel Syndrome; Inflammatory Bowel Diseases
• Other Study ID Numbers: ALPCOCAL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No