Fecal Calprotectin 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.

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Key information

Conditions

Inflammatory Bowel Diseases Abdominal Pain Body Weight Body Weight Changes Celiac Disease Chronic Diarrhea Colitis Colitis, Ulcerative Colonic Diseases Colonic Diseases, Functional Constipation Crohn Disease Digestive System Diseases Dilatation, Pathologic Distension Diverticular Diseases Diverticulitis Food Intolerance Gastroenteritis Gastrointestinal Diseases Indeterminate Colitis Intestinal Diseases Irritable Bowel Syndrome Malabsorption Syndromes Metabolic Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Ulcerative Colitis Weight Loss

Age range

4 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

One (1) Location in Dothan, Alabama, Dothan, Alabama, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stool collection

Diagnostic Test

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.

Primary outcomes

Calprotectin Stool Collection

Time frame: Through Study Completion, an average of 1 year

In vitro diagnostic (IVD) device performance

Sponsors and collaborators

Lead sponsor

DiaSorin Inc.

Industry

Registry information

Official study title

CALFE Stool Sample Collection Protocol

Acronym: CALFE

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: May 8, 2017
Registry last updated: Feb 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed