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

NCT02351635 | Completed

• 1 other identifier: ALP Cal01
• Study Type: observational
• Target: 478
• Locations: 1 country
• Sites: 7

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

Keywords

Calprotectin; Diagnosis

Outcome Measures

Primary Outcomes (1)

• Clinical value of in vitro diagnostic (IVD) device

  Sensitivity, specificity; Positive predictive value (PPV), negative predictive value (NPV) and likelihood ratios (positive and negative)

  End of Study

Secondary Outcomes (2)

• normal Calprotectin values

  End of Study

• Clinical value of IVD device in pediatric population

  End of Study

Other Outcomes (1)

• IVD Device performance

  2 months

Study Arms (5)

IBD

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

Other: fecal calprotectin level

IBS

Adult subjects with Irritable Bowel Syndrome meeting the Rome III criteria. Fecal calprotectin Level.

Other: fecal calprotectin level

other GI disorders

Adult subjects with gastrointestinal disorders other than IBD or IBS. Fecal calprotectin Level.

Other: fecal calprotectin level

pediatric

Pediatric patients (2-21 y) diagnosed with IBD, IBS, or other gastrointestinal disorders. Fecal calprotectin Level.

Other: fecal calprotectin level

healthy controls

Normal adult subjects with no abdominal complaints. Fecal calprotectin Level.

Other: fecal calprotectin level

Interventions

fecal calprotectin level OTHER

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

IBD; IBS; healthy controls; other GI disorders; pediatric

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bühlmann Laboratories AG: lead
• ICON Clinical Research: collaborator

Study Sites (7)

Stanford Center for Clinical & Translational Research & Education

Palo Alto, California, 94304, United States

Location

Gastro Health

Miami, Florida, 33173, United States

Location

Gastroenterology Assocaites of Central Georgia

Macon, Georgia, 31201, United States

Location

Carle Foundation, Center for Digestive and Liver Disease

Urbana, Illinois, 61801, United States

Location

Beth israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Great Lakes Gastroenterology Research, LLC.

Mentor, Ohio, 44060, United States

Location

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, 23320, United States

Location

Related Publications (5)

• 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.

  PMID: 22233279 BACKGROUND

• 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.

  PMID: 23449495 BACKGROUND

• 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.

  PMID: 22926499 BACKGROUND

• 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.

  PMID: 22481443 BACKGROUND

• 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.

  PMID: 20634346 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples collected before start of specific medication

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Irritable Bowel Syndrome; Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Allison Gorman

  ICON Clincal Research

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2015
• First Posted: January 30, 2015
• Study Start: January 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: April 1, 2018
• Last Updated: January 18, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)