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

NCT ID: NCT02351635

Last Updated: 2019-01-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 478 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2018-04-30

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.

Conditions

Inflammatory Bowel Disease; Irritable Bowel Syndrome

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

IBD

Adult subjects with inflammatory bowel disease, confirmed by endoscopy and histologic support. Fecal calprotectin Level.

fecal calprotectin level

Intervention Type: OTHER

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.

fecal calprotectin level

Intervention Type: OTHER

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.

fecal calprotectin level

Intervention Type: OTHER

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.

fecal calprotectin level

Intervention Type: OTHER

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.

fecal calprotectin level

Intervention Type: OTHER

Stool sample collected by the subject, sent study laboratories where fecal calprotectin levels are quantified.

Interventions

fecal calprotectin level

Stool sample collected by the subject, sent study laboratories where fecal calprotectin levels are quantified.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ICON Clinical Research

INDUSTRY

Sponsor Role: collaborator

Bühlmann Laboratories AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Allison Gorman

Role: STUDY_DIRECTOR

ICON Clincal Research

Locations

Stanford Center for Clinical & Translational Research & Education

Palo Alto, California, United States

Gastro Health

Miami, Florida, United States

Gastroenterology Assocaites of Central Georgia

Macon, Georgia, United States

Carle Foundation, Center for Digestive and Liver Disease

Urbana, Illinois, United States

Beth israel Deaconess Medical Center

Boston, Massachusetts, United States

Great Lakes Gastroenterology Research, LLC.

Mentor, Ohio, United States

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 22233279 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23449495 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22926499 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22481443 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20634346 (View on PubMed)

Other Identifiers

ALP Cal01

Identifier Type: -

Identifier Source: org_study_id