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

January 17, 2019 updated by: Bühlmann Laboratories AG

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

478

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford Center for Clinical & Translational Research & Education
    • Florida
      • Miami, Florida, United States, 33173
        • Gastro Health
    • Georgia
      • Macon, Georgia, United States, 31201
        • Gastroenterology Assocaites of Central Georgia
    • Illinois
      • Urbana, Illinois, United States, 61801
        • Carle Foundation, Center for Digestive and Liver Disease
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Ohio
      • Mentor, Ohio, United States, 44060
        • Great Lakes Gastroenterology Research, LLC.
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Gastroenterology Associates of Tidewater

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

100 adult subjects with Inflammatory Bowel Disease or Irritable Bowel Syndrome each have provided a stool sample. In addition, 50 pediatric subjects, age 2 years to 21 years, 25 subjects in each diagnostic group (IBD, IBS) will be enrolled. Recruitment of 120 normal subjects who will provide samples.

Description

Inclusion Criteria:

  1. 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.
  2. Individuals of either gender, ≥22 years of age (adult samples) or 2 to -21 years of age (pediatric samples).
  3. IBD patients whose diagnostic endoscopy occurred within the previous month.
  4. 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:

  1. Individuals unable or unwilling to provide a stool specimen.
  2. Individuals with known intestinal cancer, intestinal infection, upper gastrointestinal disease
  3. Individuals receiving chemotherapy or systemic immunosuppressive drugs.
  4. Individuals who have taken, within the previous 2 weeks, protein pump inhibitors or H2-receptor antagonists.
  5. 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.
  6. Individuals who have taken NSAIDs (nonsteroidal anti-inflammatory drugs), including aspirin, on 7 or more days during the 2 weeks before providing the sample.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical value of in vitro diagnostic (IVD) device
Time Frame: End of Study
Sensitivity, specificity; Positive predictive value (PPV), negative predictive value (NPV) and likelihood ratios (positive and negative)
End of Study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
normal Calprotectin values
Time Frame: End of Study
Calprotectin values from normal healthy donors will be calculated
End of Study
Clinical value of IVD device in pediatric population
Time Frame: 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
End of Study

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
IVD Device performance
Time Frame: 2 months
The inter-laboratory precision of the device will be investigated across the study laboratories involved.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bühlmann Laboratories AG

Collaborators

ICON Clinical Research

Investigators

  • Study Director: Allison Gorman, ICON Clincal Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

January 27, 2015

First Submitted That Met QC Criteria

January 29, 2015

First Posted (Estimate)

January 30, 2015

Study Record Updates

Last Update Posted (Actual)

January 18, 2019

Last Update Submitted That Met QC Criteria

January 17, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALP Cal01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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