Trials / Completed
CompletedNCT03143517
Fecal Calprotectin Collection Protocol
CALFE Stool Sample Collection Protocol
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 240 (actual)
- Sponsor
- DiaSorin Inc. · Industry
- Sex
- All
- Age
- 4 Years
- Healthy volunteers
- Not accepted
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.
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2017-04-19
- Primary completion
- 2018-08-23
- Completion
- 2018-08-23
- First posted
- 2017-05-08
- Last updated
- 2019-02-07
Locations
13 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT03143517. Inclusion in this directory is not an endorsement.