BÜHLMANN fCAL™ ELISA - Aid in Differentiation of IBD From IBS
Public ClinicalTrials.gov record NCT02351635. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Clinical Study of the BÜHLMANN fCAL™ ELISA as an Aid in the Differentiation of Inflammatory Bowel Disease From Irritable Bowel Syndrome
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to confirm the sensitivity and specificity of the BÜHLMANN fCAL™ ELISA as an aid in diagnosis to differentiate between Inflammatory Bowel Disease (IBD; Crohn's Disease (CD), Ulcerative Colitis (UC), or indeterminate colitis) and Irritable Bowel Syndrome (IBS). To estimate the predictive value of a positive test (positive predictive value (PPV)) and the predictive value of a negative test (Negative Predictive Value (NPV)) using the proposed test outcomes for BÜHLMANN Calprotectin Test results when used in patients referred for diagnostic evaluation with signs and symptoms suggestive of either IBS or IBD. To confirm the inter-laboratory consistency of test results for the BÜHLMANN fCAL™ ELISA. To provide exploratory observations of test results in patients between the age of 2 and 21 years. To provide a sample set from normal subjects with no symptoms or signs of gastrointestinal disease for use in Expected Value Testing.
Study identification
- NCT ID
- NCT02351635
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 478 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 22 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2014
- Primary completion
- Feb 28, 2018
- Completion
- Mar 31, 2018
- Last update posted
- Jan 17, 2019
2015 – 2018
United States locations
- U.S. sites
- 7
- U.S. states
- 7
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Stanford Center for Clinical & Translational Research & Education | Palo Alto | California | 94304 | — |
| Gastro Health | Miami | Florida | 33173 | — |
| Gastroenterology Assocaites of Central Georgia | Macon | Georgia | 31201 | — |
| Carle Foundation, Center for Digestive and Liver Disease | Urbana | Illinois | 61801 | — |
| Beth israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Great Lakes Gastroenterology Research, LLC. | Mentor | Ohio | 44060 | — |
| Gastroenterology Associates of Tidewater | Chesapeake | Virginia | 23320 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02351635, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 17, 2019 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02351635 live on ClinicalTrials.gov.