Fecal Calprotectin Collection Protocol

Completed

Conditions studied: Inflammatory Bowel Diseases, Irritable Bowel Syndrome, Ulcerative Colitis, Crohn Disease, Indeterminate Colitis, Chronic Diarrhea, Celiac Disease, Diverticulitis, Abdominal Pain, Distension, Weight Loss, Food Intolerance, Constipation

In brief

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.

Key facts

Study ID

NCT03143517

Run by

DiaSorin Inc.

People needed

240

Starts

2017-04-19

Expected to finish

2018-08-23

Last updated by the study team

2019-02-07

Who can join

Age: 4 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• One (1) Location in New York, New York — New York, New York, United States
• One (1) Location in North Carolina — Asheville, North Carolina, United States
• One (1) Location in Greenville, SC — Greenville, South Carolina, United States

Full record on ClinicalTrials.gov

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