Fecal Calprotectin Collection Protocol

Last updated: February 6, 2019
Sponsor: DiaSorin Inc.
Overall Status: Completed

Phase

N/A

Condition

Weight Loss

Diabetes Prevention

Bowel Dysfunction

Treatment

N/A

Clinical Study ID

NCT03143517
CALFE Sample Collection C-001
  • Ages > 4
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 IRBapproved 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

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 6months 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

Total Participants: 240
Study Start date:
April 19, 2017
Estimated Completion Date:
August 23, 2018

Study 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.

Connect with a study center

  • One (1) Location in Dothan, Alabama

    Dothan, Alabama 36305
    United States

    Site Not Available

  • One (1) Facility in Arkansas

    Little Rock, Arkansas 72117
    United States

    Site Not Available

  • One (1) Location in California

    Mission Hills, California 91345
    United States

    Site Not Available

  • One (1) Location in Colorado Springs, Colorado

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • One (1) Location in Lauderdale Lakes, FL

    Lauderdale Lakes, Florida 33319
    United States

    Site Not Available

  • One (1) Location in Maitland, FL

    Maitland, Florida 32751
    United States

    Site Not Available

  • One (1) Location in Miami, Florida

    Miami, Florida 33134
    United States

    Site Not Available

  • One (1) Location in St. Augustine, FL

    Saint Augustine, Florida 32086
    United States

    Site Not Available

  • One (1) Location in Atlanta, GA

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • One (1) Location in Minneapolis, MN

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • One (1) Location in New York, New York

    New York, New York 33134
    United States

    Site Not Available

  • One (1) Location in North Carolina

    Asheville, North Carolina 28801
    United States

    Site Not Available

  • One (1) Location in Greenville, SC

    Greenville, South Carolina 29615
    United States

    Site Not Available

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