Fecal Calprotectin Collection Protocol (CALFE)

February 6, 2019 updated by: DiaSorin Inc.

CALFE Stool Sample 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Dothan, Alabama, United States, 36305
        • One (1) Location in Dothan, Alabama
    • Arkansas
      • Little Rock, Arkansas, United States, 72117
        • One (1) Facility in Arkansas
    • California
      • Mission Hills, California, United States, 91345
        • One (1) Location in California
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • One (1) Location in Colorado Springs, Colorado
    • Florida
      • Lauderdale Lakes, Florida, United States, 33319
        • One (1) Location in Lauderdale Lakes, FL
      • Maitland, Florida, United States, 32751
        • One (1) Location in Maitland, FL
      • Miami, Florida, United States, 33134
        • One (1) Location in Miami, Florida
      • Saint Augustine, Florida, United States, 32086
        • One (1) Location in St. Augustine, FL
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • One (1) Location in Atlanta, GA
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • One (1) Location in Minneapolis, MN
    • New York
      • New York, New York, United States, 33134
        • One (1) Location in New York, New York
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • One (1) Location in North Carolina
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • One (1) Location in Greenville, SC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calprotectin Stool Collection
Time Frame: Through Study Completion, an average of 1 year
In vitro diagnostic (IVD) device performance
Through Study Completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DiaSorin Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2017

Primary Completion (Actual)

August 23, 2018

Study Completion (Actual)

August 23, 2018

Study Registration Dates

First Submitted

May 4, 2017

First Submitted That Met QC Criteria

May 4, 2017

First Posted (Actual)

May 8, 2017

Study Record Updates

Last Update Posted (Actual)

February 7, 2019

Last Update Submitted That Met QC Criteria

February 6, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CALFE Sample Collection C-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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