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

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02351635
• Other study ID #: ALP Cal01
• Status: Completed
• Start date: January 2015
• Est. completion date: April 2018

Study information

• Verified date: January 2019
• Source: Bühlmann Laboratories AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 478
• Est. completion date: April 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

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.

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Irritable Bowel Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Beth israel Deaconess Medical Center	Boston	Massachusetts
United States	Gastroenterology Associates of Tidewater	Chesapeake	Virginia
United States	Gastroenterology Assocaites of Central Georgia	Macon	Georgia
United States	Great Lakes Gastroenterology Research, LLC.	Mentor	Ohio
United States	Gastro Health	Miami	Florida
United States	Stanford Center for Clinical & Translational Research & Education	Palo Alto	California
United States	Carle Foundation, Center for Digestive and Liver Disease	Urbana	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Bühlmann Laboratories AG	ICON Clinical Research

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. Review. — View 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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	IVD Device performance	The inter-laboratory precision of the device will be investigated across the study laboratories involved.	2 months
Primary	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	normal Calprotectin values	Calprotectin values from normal healthy donors will be calculated	End of Study
Secondary	Clinical value of IVD device in pediatric population	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