Fecal Calprotectin Collection Protocol

Ulcerative Colitis Clinical Trial

— CALFE  

Official title:

CALFE Stool Sample Collection Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03143517
• Other study ID #: CALFE Sample Collection C-001
• Status: Completed
• Start date: April 19, 2017
• Est. completion date: August 23, 2018

Study information

• Verified date: February 2019
• Source: DiaSorin Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: August 23, 2018
• Est. primary completion date: August 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Pain
• Celiac Disease
• Chronic Diarrhea
• Colitis
• Colitis, Ulcerative
• Constipation
• Crohn Disease
• Diarrhea
• Distension
• Diverticulitis
• Food Intolerance
• Indeterminate Colitis
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Irritable Bowel Syndrome
• Ulcer
• Ulcerative Colitis
• Weight Loss

Intervention

Diagnostic Test:
• Stool collection
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.

Locations

Country	Name	City	State
United States	One (1) Location in North Carolina	Asheville	North Carolina
United States	One (1) Location in Atlanta, GA	Atlanta	Georgia
United States	One (1) Location in Colorado Springs, Colorado	Colorado Springs	Colorado
United States	One (1) Location in Dothan, Alabama	Dothan	Alabama
United States	One (1) Location in Greenville, SC	Greenville	South Carolina
United States	One (1) Location in Lauderdale Lakes, FL	Lauderdale Lakes	Florida
United States	One (1) Facility in Arkansas	Little Rock	Arkansas
United States	One (1) Location in Maitland, FL	Maitland	Florida
United States	One (1) Location in Miami, Florida	Miami	Florida
United States	One (1) Location in Minneapolis, MN	Minneapolis	Minnesota
United States	One (1) Location in California	Mission Hills	California
United States	One (1) Location in New York, New York	New York	New York
United States	One (1) Location in St. Augustine, FL	Saint Augustine	Florida

Sponsors (1)

Lead Sponsor	Collaborator
DiaSorin Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calprotectin Stool Collection	In vitro diagnostic (IVD) device performance	Through Study Completion, an average of 1 year