Fecal Calprotectin Collection Protocol

Study Overview
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Brief Summary
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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
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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.

Official Title
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CALFE Stool Sample Collection Protocol

Conditions
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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

Intervention / Treatment
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* Diagnostic Test: Stool collection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Inflammatory Bowel Disease (IBD)<br>A stool sample will be collected from adult subjects with Inflammatory Bowel Disease (IBD), confirmed by endoscopy and histologic examination. | Diagnostic Test: Stool collection<br>* 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.<br>|
| Irritable Bowel Syndrome (IBS)<br>A stool sample will be collected from adult subjects with adult subjects with Irritable Bowel Syndrome meeting the Rome III criteria. | Diagnostic Test: Stool collection<br>* 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.<br>|
| Other GastroIntestinal (GI) Disorders<br>A stool sample will be collected from adult subjects with adult subjects with gastrointestinal disorders other than IBD or IBS. | Diagnostic Test: Stool collection<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calprotectin Stool Collection | In vitro diagnostic (IVD) device performance | Through Study Completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammatory Bowel Diseases, Irritable Bowel Syndrome, Ulcerative Colitis, Crohn Disease, Indeterminate Colitis