Abdominal Pain, Celiac Disease, Chronic Diarrhea, Constipation, Crohn Disease, Distension, Diverticulitis, Food Intolerance, Indeterminate Colitis, Inflammatory Bowel Diseases, Irritable Bowel Syndrome, Ulcerative Colitis, Weight Loss
Conditions
Keywords
Inflammatory Bowel Diseases, Irritable Bowel Syndrome, Ulcerative Colitis, Crohn Disease, Indeterminate Colitis
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.
Interventions
DIAGNOSTIC_TESTStool collection
Stool sample collected by a subject who have been diagnosed with IBD, IBS or other GI disorder. The stool sample is tested in a laboratory where fecal calprotectin levels are quantified.
Sponsors
DiaSorin Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Calprotectin Stool Collection | Through Study Completion, an average of 1 year | In vitro diagnostic (IVD) device performance |
Countries
United States
Outcome results
None listed