Clinical trial NCT02351635: BÜHLMANN fCAL™ ELISA - Aid in Differentiation of IBD From IBS
Official title: Clinical Study of the BÜHLMANN fCAL™ ELISA as an Aid in the Differentiation of Inflammatory Bowel Disease From Irritable Bowel Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Disease
Irritable Bowel Syndrome
Keywords: Calprotectin
Diagnosis
Lead sponsor: Bühlmann Laboratories AG
Sponsor class: INDUSTRY
Collaborators: name: ICON Clinical Research
First posted: 2015-01-30
Enrollment: 478
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Clinical value of in vitro diagnostic (IVD) device
timeFrame: End of Study
Secondary outcomes:
measure: normal Calprotectin values
timeFrame: End of Study
measure: Clinical value of IVD device in pediatric population
timeFrame: End of Study
Other outcomes:
measure: IVD Device performance
timeFrame: 2 months
Locations:
city: Palo Alto
country: United States
facility: Stanford Center for Clinical & Translational Research & Education
state: California
city: Miami
country: United States
facility: Gastro Health
state: Florida
city: Macon
country: United States
facility: Gastroenterology Assocaites of Central Georgia
state: Georgia
city: Urbana
country: United States
facility: Carle Foundation, Center for Digestive and Liver Disease
state: Illinois
city: Boston
country: United States
facility: Beth israel Deaconess Medical Center
state: Massachusetts
city: Mentor
country: United States
facility: Great Lakes Gastroenterology Research, LLC.
state: Ohio
city: Chesapeake
country: United States
facility: Gastroenterology Associates of Tidewater
state: Virginia
Study officials:
affiliation: ICON Clincal Research
name: Allison Gorman
role: STUDY_DIRECTOR
References:
citation: Manz M, Burri E, Rothen C, Tchanguizi N, Niederberger C, Rossi L, Beglinger C, Lehmann FS. Value of fecal calprotectin in the evaluation of patients with abdominal discomfort: an observational study. BMC Gastroenterol. 2012 Jan 10;12:5. doi: 10.1186/1471-230X-12-5.
citation: Occhipinti K, Smith JW. Irritable bowel syndrome: a review and update. Clin Colon Rectal Surg. 2012 Mar;25(1):46-52. doi: 10.1055/s-0032-1301759.
citation: Kappelman MD, Moore KR, Allen JK, Cook SF. Recent trends in the prevalence of Crohn's disease and ulcerative colitis in a commercially insured US population. Dig Dis Sci. 2013 Feb;58(2):519-25. doi: 10.1007/s10620-012-2371-5. Epub 2012 Aug 29.
citation: Burri E, Beglinger C. Faecal calprotectin -- a useful tool in the management of inflammatory bowel disease. Swiss Med Wkly. 2012 Apr 5;142:w13557. doi: 10.4414/smw.2012.13557. eCollection 2012.
citation: van Rheenen PF, Van de Vijver E, Fidler V. Faecal calprotectin for screening of patients with suspected inflammatory bowel disease: diagnostic meta-analysis. BMJ. 2010 Jul 15;341:c3369. doi: 10.1136/bmj.c3369.