Fecal Calprotectin Collection Protocol

Completed

• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Food Intolerance; Constipation; Irritable Bowel Syndrome; Chronic Diarrhea; Celiac Disease; Abdominal Pain; Distension; Ulcerative Colitis

• Registration Number: NCT03143517
• Lead Sponsor: DiaSorin Inc.

Brief Summary

The primary objective is to obtain stool samples from subjects diagnosed with , and displaying signs and/or symptoms of IBD and/or IBS will be evaluated in this study. Eligible subjects require a diagnostic colonoscopy with possible biopsy and clinical evaluation.

Detailed Description

Stools will be collected and tested, at a later date, in a clinical performance study with an investigational Calprotectin assay. This study will be coordinated by the Sponsor.

Study Timeline

• Study Start: 2017-04-19
• Study First Submitted: 2017-05-04
• Study First Submitted QC: 2017-05-04
• Study First Posted: 2017-05-08
• Primary Completion: 2018-08-23
• Study Completion: 2018-08-23
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-06
• Last Update Posted: 2019-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• Subject is of either gender and ≥ 4 years of age.
• Subject is showing signs and symptoms of IBD and/or IBS.
• Diagnosis of IBD, IBS or other gastrointestinal disorder is performed by colonoscopy.
• Subject or authorized legal representative is willing and able to sign the IRB approved Informed Consent form or able to provide Informed Consent in accordance with 21 CFR 50 CFR 50 Subpart B.
• Subject is able to understand and follow study sample collection procedure.

Exclusion Criteria

• Subject has undergone a surgical resection or diversion procedure.
• Subject is currently taking NSAIDS (non-steroidal anti-inflammatory drugs, i.e. ibuprofen, Advil, Motrin, Naproxen, Aleve including regular dose and low dose aspirin) within 7 days of colonoscopy and sample collection.
• Subject who has taken immunomodulators or biologic therapies within the previous 6 months of colonoscopy and sample collection.
• Subject who is currently pregnant or lactating.
• Subject is unable or unwilling to follow informed consent.
• Inability or unwilling to perform required study procedures.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Calprotectin Stool Collection	Through Study Completion, an average of 1 year	In vitro diagnostic (IVD) device performance

Trial Locations

Locations (13)

One (1) Location in Dothan, Alabama; 🇺🇸 Dothan, Alabama, United States

One (1) Facility in Arkansas; 🇺🇸 Little Rock, Arkansas, United States

One (1) Location in California; 🇺🇸 Mission Hills, California, United States

One (1) Location in Colorado Springs, Colorado; 🇺🇸 Colorado Springs, Colorado, United States

One (1) Location in Lauderdale Lakes, FL; 🇺🇸 Lauderdale Lakes, Florida, United States

One (1) Location in Maitland, FL; 🇺🇸 Maitland, Florida, United States

One (1) Location in Miami, Florida; 🇺🇸 Miami, Florida, United States

One (1) Location in St. Augustine, FL; 🇺🇸 Saint Augustine, Florida, United States

One (1) Location in Atlanta, GA; 🇺🇸 Atlanta, Georgia, United States

One (1) Location in Minneapolis, MN; 🇺🇸 Minneapolis, Minnesota, United States

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