Fecal Calprotectin Collection Protocol

NCT03143517 | Completed

• 1 other identifier: CALFE Sample Collection C-001
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 13

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.

Conditions

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

Keywords

Inflammatory Bowel Diseases; Irritable Bowel Syndrome; Ulcerative Colitis; Crohn Disease; Indeterminate Colitis

Outcome Measures

Primary Outcomes (1)

• Calprotectin Stool Collection

  In vitro diagnostic (IVD) device performance

  Through Study Completion, an average of 1 year

Study Arms (3)

Inflammatory Bowel Disease (IBD)

A stool sample will be collected from adult subjects with Inflammatory Bowel Disease (IBD), confirmed by endoscopy and histologic examination.

Diagnostic Test: Stool collection

Irritable Bowel Syndrome (IBS)

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

Other GastroIntestinal (GI) Disorders

A stool sample will be collected from adult subjects with adult subjects with gastrointestinal disorders other than IBD or IBS.

Diagnostic Test: Stool collection

Interventions

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.

Inflammatory Bowel Disease (IBD); Irritable Bowel Syndrome (IBS); Other GastroIntestinal (GI) Disorders

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult subjects and belonging to the target population, i.e. patients diagnosed with IBD, specifically CD, UC, or IC, patients diagnosed with IBS, and patients diagnosed with other gastrointestinal diseases, e.g. Celiac Disease, Diverticular Disease, Chronic Diarrhea and Recurrent Abdominal Pain (RAP).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• DiaSorin Inc.: lead

Study Sites (13)

One (1) Location in Dothan, Alabama

Dothan, Alabama, 36305, United States

Location

One (1) Facility in Arkansas

Little Rock, Arkansas, 72117, United States

Location

One (1) Location in California

Mission Hills, California, 91345, United States

Location

One (1) Location in Colorado Springs, Colorado

Colorado Springs, Colorado, 80907, United States

Location

One (1) Location in Lauderdale Lakes, FL

Lauderdale Lakes, Florida, 33319, United States

Location

One (1) Location in Maitland, FL

Maitland, Florida, 32751, United States

Location

One (1) Location in Miami, Florida

Miami, Florida, 33134, United States

Location

One (1) Location in St. Augustine, FL

Saint Augustine, Florida, 32086, United States

Location

One (1) Location in Atlanta, GA

Atlanta, Georgia, 30342, United States

Location

One (1) Location in Minneapolis, MN

Minneapolis, Minnesota, 55455, United States

Location

One (1) Location in New York, New York

New York, New York, 33134, United States

Location

One (1) Location in North Carolina

Asheville, North Carolina, 28801, United States

Location

One (1) Location in Greenville, SC

Greenville, South Carolina, 29615, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Human Stool

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Irritable Bowel Syndrome; Colitis, Ulcerative; Crohn Disease; Celiac Disease; Diverticulitis; Abdominal Pain; Dilatation, Pathologic; Weight Loss; Food Intolerance; Constipation

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Colitis; Malabsorption Syndromes; Metabolic Diseases; Nutritional and Metabolic Diseases; Diverticular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Pathological Conditions, Anatomical; Body Weight Changes; Body Weight

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 8, 2017
• Study Start: April 19, 2017
• Primary Completion: August 23, 2018
• Study Completion: August 23, 2018
• Last Updated: February 7, 2019

Record last verified: 2019-02

Locations

US (13)