Clinical trial NCT03566407: Blood and Stool Molecular Biomarkers Longitudinal Detection Study in Crohn's Disease (CD) Patients
Official title: Blood and Stool Molecular Biomarkers Longitudinal Detection Study in Crohn's Disease (CD) Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Crohn's Disease
Lead sponsor: Prometheus Laboratories
Sponsor class: INDUSTRY
First posted: 2018-06-25
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All study subjects will undergo a protocol required 6 month colonoscopy
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. 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.
3. 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.
4. 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.
5. Understand the procedures and requirements of the study by providing written informed consent including consent and authorization for protected health information disclosure.

Exclusion Criteria:

1. Extensive small bowel resection or short bowel syndrome.
2. Surgery for CD within the 6 months previous to enrollment.
3. Receipt of any blood products within 3 months prior to study entry.
4. Known pregnancy or breast feeding within 3 months of specimen collection.
5. Recent history of viral or bacterial gastroenteritis including Clostridium difficile infection \< 4 weeks prior to the blood draw
6. Concurrent diagnosis of another currently active erosive GI mucosal disease such as erosive esophagitis, gastric or duodenal ulcer, celiac sprue, diverticulitis, etc.
7. History of intestinal or colorectal cancer, of active autoimmune diseases, or of other chronic uncontrolled systemic disorders
8. History of bowel prep within the past 3 months.
9. History of alcohol or substance abuse.
10. History of prior colectomy or stricturing disease that could limit colonoscopy examination of small bowel mucosa.
11. Current ostomy or ileoanal pouch.
12. Current or previous (of less than 4 weeks prior) participation in in a clinical trial for an investigational drug.

Primary outcomes:
measure: Assess disease status biomarkers against colonoscopy
timeFrame: 6 months
measure: Assess disease status biomarkers against colonoscopy
timeFrame: 6 months
Secondary outcomes:
measure: Assess bacterial markers in stool against colonoscopy scoring system Simple Endoscopic Score for Crohn's Disease (SES-CD)
timeFrame: 6 months
measure: Assess bacterial markers in stool against colonoscopy scoring system Crohn's Disease Endoscopic Index of Severity (CDEIS)
timeFrame: 6 months
measure: Assess bacterial markers in stool against disease symptomology scored by Harvey Bradshaw Index (HBI) for clinical evaluation
timeFrame: 6 months
measure: Assess bacterial markers in stool against disease symptomology scored by Crohn's Disease Activity Index (CDAI) for clinical evaluation
timeFrame: 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Ventura
country: United States
facility: Ventura Clinical Trials, LLC.
state: California
city: Hamden
country: United States
facility: Medical Research Center of Connecticut, LLC
state: Connecticut
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates, LLC
state: Georgia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Prometheus Laboratories
name: Clinical Development and Medical Affairs
role: STUDY_CHAIR
References: