Fecal Calprotectin Collection Protocol
CompletedNCT03143517
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- Official title
- CALFE Stool Sample Collection Protocol
- 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
- Interventions
- Diagnostic test: Stool collection
- Sponsor
- DiaSorin Inc.
- Start date
- 2017-04-19
- Primary completion
- 2018-08-23
- Sex
- All
- Age range
- from 4 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 13
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03143517