CALFE: Fecal Calprotectin Collection Protocol

Sponsor

DiaSorin Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03143517

Collaborator

(none)

240

Enrollment

Locations

16.1

Actual Duration (Months)

18.5

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Diagnostic Test: Stool collection

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.

Study Design

Study Type:

Observational

Actual Enrollment :

240 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

CALFE Stool Sample Collection Protocol

Actual Study Start Date :

Apr 19, 2017

Actual Primary Completion Date :

Aug 23, 2018

Actual Study Completion Date :

Aug 23, 2018

Arms and Interventions

Arm	Intervention/Treatment
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 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.
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 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.
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 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.

Arm

Intervention/Treatment

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

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.

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

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.

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

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.

Outcome Measures

Primary Outcome Measures

Calprotectin Stool Collection [Through Study Completion, an average of 1 year]
In vitro diagnostic (IVD) device performance

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	One (1) Location in Dothan, Alabama	Dothan	Alabama	United States	36305
2	One (1) Facility in Arkansas	Little Rock	Arkansas	United States	72117
3	One (1) Location in California	Mission Hills	California	United States	91345
4	One (1) Location in Colorado Springs, Colorado	Colorado Springs	Colorado	United States	80907
5	One (1) Location in Lauderdale Lakes, FL	Lauderdale Lakes	Florida	United States	33319
6	One (1) Location in Maitland, FL	Maitland	Florida	United States	32751
7	One (1) Location in Miami, Florida	Miami	Florida	United States	33134
8	One (1) Location in St. Augustine, FL	Saint Augustine	Florida	United States	32086
9	One (1) Location in Atlanta, GA	Atlanta	Georgia	United States	30342
10	One (1) Location in Minneapolis, MN	Minneapolis	Minnesota	United States	55455
11	One (1) Location in New York, New York	New York	New York	United States	33134
12	One (1) Location in North Carolina	Asheville	North Carolina	United States	28801
13	One (1) Location in Greenville, SC	Greenville	South Carolina	United States	29615