Clinical Trial Details

Overview

Research Study Summary

Clincial Study of the BUHLMANN fCAL ELISA as an Aid in the Differentiation of Inflammatory Bowel Disease from Irritable Bowel Syndrome

Purpose

The purpose of this study is to confirm the sensitivity and specificity of the BUHLMANN fCAL ELISA in patients, as an aid in diagnosis to differntiate between Inflammatory Bowel Disease (Crohn's Disease, Ulcerative Colitis, or indeterminate colitis) and Irritable Bowel Syndrome.

To Learn more

CW ID: 213280
Date Last Changed: February 16, 2016

Clinical Trial Snapshot

Gender
Both Male and Female
Age
22 and up
Overall Status
Recruiting
Lead Sponsor
BUHLMANN Laboratories
Facility Type
Out-Patient
Compensation
Up to $50

Eligibility

Inclusion Criteria (IBD Patients):

  • Patients who are referred for suspected IBD symptoms
  • Subjects must be treatment naive, or must provide stool sample within 1 week after initiation of treatment (*treatment specific exclusions apply)
  • Have had a colonoscopy within 30 days prior to signing consent, or will be having one after consent is signed

Inclusion Criteria (IBS Patients):

  • Patients who are referred for suspected IBS symptoms
  • Have had a colonoscopy within 30 days prior to signing consent, or will be having one after consent is signed

Exclusion Criteria (for BOTH IBD and IBS Patients):

  • Intestinal Cancer
  • Intestinal infections
  • Upper gastrointestinal disease (e.g. esophagitis or gastritis)
  • Individuals who have taken aspirin during the last 7 days, except those who take it regularly for cardiovascular reasons
  • Individuals who have taken proton pump inhibitors (PPIs; e.g. Prilosec, Prevacid, Zegerid, or Protonix), within the previous 7 days; however, subjects may interrupt PPI therapy for 7 days prior to collecting the stool sample, and then resume treatment
  • Individuals who have taken H2-receptor antagonists (e.g. Tagamet, Pepcid, or Zantac) within the previous 2 weeks
  • Individuals who are scheduled for their colonoscopy within 24 hours after

Contact

MariCarmen Korngiebel-Rosique, MS, CRC, Clinical Research Coordinator
Gastroenterology Associates of Tidewater
112 Gainsborough Square; Suite 200
Chesapeake, VA 23320
Phone: 757-547-0798; ext 1122
Fax: 757-410-4123

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Research Center Information:

Gastroenterology Associates of Tidewater

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