Blood and Stool Molecular Biomarkers Longitudinal Detection Study in Crohn's Disease (CD) Patients

Prometheus Laboratories5 sites in 1 country41 target enrollmentMay 4, 2018

ConditionsCrohn's Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Crohn's Disease
Sponsor: Prometheus Laboratories
Enrollment: 41
Locations: 5
Primary Endpoint: Assess disease status biomarkers against colonoscopy
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To evaluate the relationship between noninvasive biomarkers (patient serological markers and metagenomic analysis of stool) and disease status as determined by colonoscopy and by clinical symptoms in patients with Crohn's disease, and to evaluate whether changes in the biomarker levels over time correlate to changes in the state of patients' disease.

Registry

clinicaltrials.gov

Start Date

May 4, 2018

End Date

March 29, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Prometheus Laboratories

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males and females with CD who are 18 years of age or older on the date of obtaining informed consent and are undergoing a colonoscopy at the study site.
•The patient must have a confirmed diagnosis of CD based on results a complete medical evaluation and the assessment by a physician specialized in inflammatory bowel disease.
•All CD patients should have no evidence for another active organic disease of the GI tract or medical problems as specified below in the exclusion criteria.
•All patients must have a colonoscopic examination performed preferably on the same day as blood specimen is drawn, or blood may be drawn up to one week prior to colonoscopy. Stool specimen will be collected prior to the beginning of bowel prep for the colonoscopy, up to 10 days prior to bowel prep.
•Understand the procedures and requirements of the study by providing written informed consent including consent and authorization for protected health information disclosure.

Exclusion Criteria

•Extensive small bowel resection or short bowel syndrome.
•Surgery for CD within the 6 months previous to enrollment.
•Receipt of any blood products within 3 months prior to study entry.
•Known pregnancy or breast feeding within 3 months of specimen collection.
•Recent history of viral or bacterial gastroenteritis including Clostridium difficile infection \< 4 weeks prior to the blood draw
•Concurrent diagnosis of another currently active erosive GI mucosal disease such as erosive esophagitis, gastric or duodenal ulcer, celiac sprue, diverticulitis, etc.
•History of intestinal or colorectal cancer, of active autoimmune diseases, or of other chronic uncontrolled systemic disorders
•History of bowel prep within the past 3 months.
•History of alcohol or substance abuse.
•History of prior colectomy or stricturing disease that could limit colonoscopy examination of small bowel mucosa.

Outcomes

Primary Outcomes

Assess disease status biomarkers against colonoscopy

Time Frame: 6 months

The primary endpoint for assessing clinical validity of candidate biomarker will also be correlated to the degree of mucosal healing as determined by colonoscopy scored by the Crohn's Disease Endoscopic Index of Severity (CDEIS). A scale that via colonoscopy of Crohn's disease patient's measures: 1. Deep Ulcerations 2. Superficial Ulcerations 3. Surface involved by disease and 4.Surface involved by ulcerations. Scale goes from 0 to 44 with a higher score indicating greater severity of disease.

Secondary Outcomes

Assess bacterial markers in stool against colonoscopy scoring system Simple Endoscopic Score for Crohn's Disease (SES-CD)(6 months)
Assess bacterial markers in stool against colonoscopy scoring system Crohn's Disease Endoscopic Index of Severity (CDEIS)(6 months)
Assess bacterial markers in stool against disease symptomology scored by Harvey Bradshaw Index (HBI) for clinical evaluation(6 months)
Assess bacterial markers in stool against disease symptomology scored by Crohn's Disease Activity Index (CDAI) for clinical evaluation(6 months)