BÜHLMANN fCAL™ ELISA - Aid in Differentiation of IBD From IBS

Sponsor

Bühlmann Laboratories AG (Industry)

Overall Status

Completed

CT.gov ID

NCT02351635

Collaborator

ICON Clinical Research (Industry)

478

Enrollment

Locations

Duration (Months)

68.3

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Disease Irritable Bowel Syndrome	Other: fecal calprotectin level

Study Design

Study Type:

Observational

Actual Enrollment :

478 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Clinical Study of the BÜHLMANN fCAL™ ELISA as an Aid in the Differentiation of Inflammatory Bowel Disease From Irritable Bowel Syndrome

Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Mar 1, 2018

Actual Study Completion Date :

Apr 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
IBD Adult subjects with inflammatory bowel disease, confirmed by endoscopy and histologic support. Fecal calprotectin Level.	Other: fecal calprotectin level Stool sample collected by the subject, sent study laboratories where fecal calprotectin levels are quantified.
IBS Adult subjects with Irritable Bowel Syndrome meeting the Rome III criteria. Fecal calprotectin Level.	Other: fecal calprotectin level Stool sample collected by the subject, sent study laboratories where fecal calprotectin levels are quantified.
other GI disorders Adult subjects with gastrointestinal disorders other than IBD or IBS. Fecal calprotectin Level.	Other: fecal calprotectin level Stool sample collected by the subject, sent study laboratories where fecal calprotectin levels are quantified.
pediatric Pediatric patients (2-21 y) diagnosed with IBD, IBS, or other gastrointestinal disorders. Fecal calprotectin Level.	Other: fecal calprotectin level Stool sample collected by the subject, sent study laboratories where fecal calprotectin levels are quantified.
healthy controls Normal adult subjects with no abdominal complaints. Fecal calprotectin Level.	Other: fecal calprotectin level Stool sample collected by the subject, sent study laboratories where fecal calprotectin levels are quantified.

Outcome Measures

Primary Outcome Measures

Clinical value of in vitro diagnostic (IVD) device [End of Study]
Sensitivity, specificity; Positive predictive value (PPV), negative predictive value (NPV) and likelihood ratios (positive and negative)

Secondary Outcome Measures

normal Calprotectin values [End of Study]
Calprotectin values from normal healthy donors will be calculated
Clinical value of IVD device in pediatric population [End of Study]
Results of the pediatric population will be used as preliminary and exploratory evidence that calprotectin test can be used in this population

Other Outcome Measures

IVD Device performance [2 months]
The inter-laboratory precision of the device will be investigated across the study laboratories involved.

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Adults or pediatric patients evaluated by a gastroenterological service for investigation of possible inflammatory intestinal disease or IBS. Patients are referred for sub-specialty evaluation of symptoms such as abdominal pain, diarrhea, altered appetite, weight loss, or anemia.

IBD: Eligible subjects will be analyzed as patients with IBD after a confirmed diagnosis of Inflammatory Bowel Disease (CD, UC, or Indeterminate Colitis), based on endoscopy and confirmed by histology of biopsies taken during endoscopy.
IBS: Eligible candidate subjects can also include patients who are self-referred with the relevant constellation of complaints. Eligible subjects will be enrolled after having a diagnosis of IBS based on the Rome III criteria confirmed by negative endoscopy including the colon and terminal ileum.
other GI Disorders: Eligible subjects will be enrolled after having a diagnosis of a gastrointestinal disorder other than IBD or IBS, confirmed by endoscopy results and other appropriate diagnostic studies.
Healthy Controls: Adults (≥22) with no abdominal complaints and no history of IBS, IBD or other chronic intestinal disorder, confirmed by medical history and physical examination at enrolment.

Individuals of either gender, ≥22 years of age (adult samples) or 2 to -21 years of age (pediatric samples).
IBD patients whose diagnostic endoscopy occurred within the previous month.
Individuals able to understand the study and the tasks required, and who sign the Informed Consent Form (adult subjects; ICF) or whose parent/guardian provides consent (ICF) and, if age 7-to-18 years of age, who provide assent (pediatric subjects).

Exclusion Criteria:

Individuals unable or unwilling to provide a stool specimen.
Individuals with known intestinal cancer, intestinal infection, upper gastrointestinal disease
Individuals receiving chemotherapy or systemic immunosuppressive drugs.
Individuals who have taken, within the previous 2 weeks, protein pump inhibitors or H2-receptor antagonists.
Individuals with previously diagnosed Inflammatory Bowel Disease managed with immunomodulators, 5-ASA (5-aminosalicylic acid) or biologic therapies or who have undergone a surgical resection or diversion procedure.
Individuals who have taken NSAIDs (nonsteroidal anti-inflammatory drugs), including aspirin, on 7 or more days during the 2 weeks before providing the sample.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford Center for Clinical & Translational Research & Education	Palo Alto	California	United States	94304
2	Gastro Health	Miami	Florida	United States	33173
3	Gastroenterology Assocaites of Central Georgia	Macon	Georgia	United States	31201
4	Carle Foundation, Center for Digestive and Liver Disease	Urbana	Illinois	United States	61801
5	Beth israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
6	Great Lakes Gastroenterology Research, LLC.	Mentor	Ohio	United States	44060
7	Gastroenterology Associates of Tidewater	Chesapeake	Virginia	United States	23320