Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Bühlmann Laboratories AG

Collaborator: ICON Clinical Research

Stanford Investigator(s):

Intervention(s):

  • Other: fecal calprotectin level

Phase:

N/A

Eligibility


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.

Ages Eligible for Study

22 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Elisabeth Merkel
650-736-0644
Not Recruiting