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Fecal Calprotectin Collection Protocol | Clinical Trials | Clareo Health

COMPLETED

Fecal Calprotectin Collection Protocol

CALFE Stool Sample Collection Protocol

NCT03143517•DiaSorin Inc.

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

Age

4 - No limit years

Sex

ALL

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.

Locations (13)

One (1) Location in Dothan, Alabama

Dothan, Alabama, United States

One (1) Facility in Arkansas

Little Rock, Arkansas, United States

One (1) Location in California

Mission Hills, California, United States

One (1) Location in Colorado Springs, Colorado

Colorado Springs, Colorado, United States

One (1) Location in Lauderdale Lakes, FL

Lauderdale Lakes, Florida, 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 St. Augustine, FL

Saint Augustine, Florida, United States

One (1) Location in Atlanta, GA

Atlanta, Georgia, United States

One (1) Location in Minneapolis, MN

Minneapolis, Minnesota, United States

Key Dates

Start Date

April 19, 2017

Primary Completion Date

August 23, 2018

Completion Date

August 23, 2018

Last Updated

February 7, 2019

Enrollment

240

ACTUAL participants

Conditions

Inflammatory Bowel DiseasesIrritable Bowel SyndromeUlcerative ColitisCrohn DiseaseIndeterminate ColitisChronic DiarrheaCeliac DiseaseDiverticulitisAbdominal PainDistensionWeight LossFood IntoleranceConstipation

Interventions

Stool collection

DIAGNOSTIC_TEST

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

NCT06226883

Inflammatory Bowel DiseasesCrohn's Disease

View study

RECRUITINGPHASE1/PHASE2

Safety and Efficacy of Lyophilized Faecal Microbiota Transplantation Via Capsules in Treatment of Irritable Bowel Syndrome

NCT07481422

Irritable Bowel Syndrome (IBS)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 7, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Fecal Calprotectin Collection Protocol

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

Safety and Efficacy of Lyophilized Faecal Microbiota Transplantation Via Capsules in Treatment of Irritable Bowel Syndrome

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis