Fecal Calprotectin Collection Protocol

CALFE Stool Sample Collection Protocol

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.

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.

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.