Clinical trial NCT03143517: Fecal Calprotectin Collection Protocol
Official title: CALFE Stool Sample Collection Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: DiaSorin Inc.
Sponsor class: INDUSTRY
First posted: 2017-05-08
Enrollment: 240
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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).

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.

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.

Primary outcomes:
measure: Calprotectin Stool Collection
timeFrame: Through Study Completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Dothan
country: United States
facility: One (1) Location in Dothan, Alabama
state: Alabama
city: Little Rock
country: United States
facility: One (1) Facility in Arkansas
state: Arkansas
city: Mission Hills
country: United States
facility: One (1) Location in California
state: California
city: Colorado Springs
country: United States
facility: One (1) Location in Colorado Springs, Colorado
state: Colorado
city: Lauderdale Lakes
country: United States
facility: One (1) Location in Lauderdale Lakes, FL
state: Florida
city: Maitland
country: United States
facility: One (1) Location in Maitland, FL
state: Florida
city: Miami
country: United States
facility: One (1) Location in Miami, Florida
state: Florida
city: Saint Augustine
country: United States
facility: One (1) Location in St. Augustine, FL
state: Florida
city: Atlanta
country: United States
facility: One (1) Location in Atlanta, GA
state: Georgia
city: Minneapolis
country: United States
facility: One (1) Location in Minneapolis, MN
state: Minnesota
city: New York
country: United States
facility: One (1) Location in New York, New York
state: New York
city: Asheville
country: United States
facility: One (1) Location in North Carolina
state: North Carolina
city: Greenville
country: United States
facility: One (1) Location in Greenville, SC
state: South Carolina
Study officials:
References: