CALFE Stool Sample Collection Protocol

DiaSorin Inc.13 sites in 1 country240 target enrollmentApril 19, 2017

ConditionsInflammatory Bowel Diseases Irritable Bowel Syndrome Ulcerative Colitis Crohn Disease Indeterminate Colitis Chronic Diarrhea Celiac Disease Diverticulitis Abdominal Pain Distension Weight Loss Food Intolerance Constipation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Inflammatory Bowel Diseases
Sponsor: DiaSorin Inc.
Enrollment: 240
Locations: 13
Primary Endpoint: Calprotectin Stool Collection
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 19, 2017

End Date

August 23, 2018

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

DiaSorin Inc.

Responsible Party

Sponsor

Eligibility Criteria

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.