Fecal Calprotectin Collection Protocol
- Conditions
- Inflammatory Bowel DiseasesCrohn DiseaseFood IntoleranceConstipationIrritable Bowel SyndromeChronic DiarrheaCeliac DiseaseAbdominal PainDistensionUlcerative Colitis
- Interventions
- Diagnostic Test: Stool collection
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
- 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.
- 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
- Arm && Interventions
Group Intervention Description Inflammatory Bowel Disease (IBD) Stool collection A stool sample will be collected from adult subjects with Inflammatory Bowel Disease (IBD), confirmed by endoscopy and histologic examination. Other GastroIntestinal (GI) Disorders Stool collection A stool sample will be collected from adult subjects with adult subjects with gastrointestinal disorders other than IBD or IBS. Irritable Bowel Syndrome (IBS) Stool collection A stool sample will be collected from adult subjects with adult subjects with Irritable Bowel Syndrome meeting the Rome III criteria.
- Primary Outcome Measures
Name Time Method Calprotectin Stool Collection Through Study Completion, an average of 1 year In vitro diagnostic (IVD) device performance
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (13)
One (1) Location in Lauderdale Lakes, FL
🇺🇸Lauderdale Lakes, Florida, United States
One (1) Location in Colorado Springs, Colorado
🇺🇸Colorado Springs, Colorado, United States
One (1) Location in California
🇺🇸Mission Hills, California, United States
One (1) Location in Maitland, FL
🇺🇸Maitland, Florida, United States
One (1) Facility in Arkansas
🇺🇸Little Rock, Arkansas, United States
One (1) Location in St. Augustine, FL
🇺🇸Saint Augustine, Florida, United States
One (1) Location in New York, New York
🇺🇸New York, New York, United States
One (1) Location in Greenville, SC
🇺🇸Greenville, South Carolina, United States
One (1) Location in Dothan, Alabama
🇺🇸Dothan, Alabama, United States
One (1) Location in Miami, Florida
🇺🇸Miami, 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 North Carolina
🇺🇸Asheville, North Carolina, United States