Back to resultsBlood and Stool Molecular Biomarkers Longitudinal Detection Study in Crohn's Disease (CD) Patients
Primary Purpose
Crohn's Disease
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Colonoscopy
Sponsored by
About this trial
This is an interventional other trial for Crohn's Disease
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.
- Current ostomy or ileoanal pouch.
- Current or previous (of less than 4 weeks prior) participation in in a clinical trial for an investigational drug.
Sites / Locations
- University of Southern California
- Ventura Clinical Trials, LLC.
- Medical Research Center of Connecticut, LLC
- Atlanta Gastroenterology Associates, LLC
- Medical College of Wisconsin
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single Group
Arm Description
This is a prospective, longitudinal descriptive study of subjects with diagnosed Crohn's disease. Blood samples for measurement of protein biomarkers (serology), fresh whole blood for detection of gene polymorphisms, and stool samples for detection and assessment of microbiome and host DNA will be collected, and colonoscopy will be performed.
Outcomes
Primary Outcome Measures
Assess disease status biomarkers against colonoscopy
The primary endpoint for assessing clinical validity of candidate biomarker will be correlation to the degree of mucosal healing as determined by colonoscopy scored by the Simple Endoscopic Score for Crohn's Disease (SES-CD). - A scale that via colonoscopy of Crohn's disease patients measures: 1. Presence and size of ulcers 2. Extent of ulcerated surface 3. Extent of affected surface and 4. Presence and type of intestinal narrowings. Scale goes from 0 to 56 with a higher score indicating greater severity of disease.
Assess disease status biomarkers against colonoscopy
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 Outcome Measures
Assess bacterial markers in stool against colonoscopy scoring system Simple Endoscopic Score for Crohn's Disease (SES-CD)
Identify the correlation of the quantity of specific bacterial markers in the stool as quantified by a stool-based algorithm to the clinical state of the colonoscopy procedure scored by SES-CD tool. Simple Endoscopic Score for Crohn's Disease (SES-CD) - A scale that via colonoscopy of Crohn's disease patients measures: 1.Presence and size of ulcers 2. Extent of ulcerated surface 3. Extent of affected surface and 4. Presence and type of intestinal narrowings. Scale goes from 0 to 56 with a higher score indicating greater severity of disease.
Assess bacterial markers in stool against colonoscopy scoring system Crohn's Disease Endoscopic Index of Severity (CDEIS)
Identify the correlation of the quantity of specific bacterial markers in the stool as quantified by a stool-based algorithm to the clinical state of the colonoscopy procedure scored by CDEIS tool. 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.
Assess bacterial markers in stool against disease symptomology scored by Harvey Bradshaw Index (HBI) for clinical evaluation
Determine the correlation of the quantity of specific bacterial markers in the stool as quantified by a stool-based algorithm to the clinical symptoms that measure stool frequency and symptomology by the Harvey Bradshaw Index (HBI) tool. Harvey Bradshaw Index (HBI) - A scale that assesses Crohn's disease patients' signs and symptoms by measuring : 1. General well-being 2. Abdominal pain 3. Number of liquid stools per day 4. Presence of abdominal mass and 5. Complications. Scale goes from 0 to 18 with a higher score indicating greater severity of disease.
Assess bacterial markers in stool against disease symptomology scored by Crohn's Disease Activity Index (CDAI) for clinical evaluation
Determine the correlation of the quantity of specific bacterial markers in the stool as quantified by a stool-based algorithm to the clinical symptoms that measure stool frequency and symptomology by the Crohn's Disease Activity Index (CDAI) tool. Crohn's Disease Activity Index (CDAI) - A scale that assesses Crohn's disease patients' signs and symptoms by measuring: 1. Number of liquid or soft stools each day for seven days 2. Abdominal pain each day for seven day 3. General well-being, subjectively assessed for day for seven days 4. Presence of complications 5. Taking anti-diarrhea medications 6. Presence of an abdominal mass 7.Hematocrit and 8. Percentage deviation from standard weight. Scale goes from 0 to >600 with a higher score indicating greater severity of disease.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03566407
Brief Title
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
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decided to discontinue the study due to poor enrollment.
Study Start Date
May 4, 2018 (Actual)
Primary Completion Date
March 29, 2019 (Actual)
Study Completion Date
March 29, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prometheus Laboratories
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All study subjects will undergo a protocol required 6 month colonoscopy
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Group
Arm Type
Other
Arm Description
This is a prospective, longitudinal descriptive study of subjects with diagnosed Crohn's disease. Blood samples for measurement of protein biomarkers (serology), fresh whole blood for detection of gene polymorphisms, and stool samples for detection and assessment of microbiome and host DNA will be collected, and colonoscopy will be performed.
Intervention Type
Procedure
Intervention Name(s)
Colonoscopy
Intervention Description
Colonoscopy will be required for all subjects at 6 months - Visit 3.
Primary Outcome Measure Information:
Title
Assess disease status biomarkers against colonoscopy
Description
The primary endpoint for assessing clinical validity of candidate biomarker will be correlation to the degree of mucosal healing as determined by colonoscopy scored by the Simple Endoscopic Score for Crohn's Disease (SES-CD). - A scale that via colonoscopy of Crohn's disease patients measures: 1. Presence and size of ulcers 2. Extent of ulcerated surface 3. Extent of affected surface and 4. Presence and type of intestinal narrowings. Scale goes from 0 to 56 with a higher score indicating greater severity of disease.
Time Frame
6 months
Title
Assess disease status biomarkers against colonoscopy
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Assess bacterial markers in stool against colonoscopy scoring system Simple Endoscopic Score for Crohn's Disease (SES-CD)
Description
Identify the correlation of the quantity of specific bacterial markers in the stool as quantified by a stool-based algorithm to the clinical state of the colonoscopy procedure scored by SES-CD tool. Simple Endoscopic Score for Crohn's Disease (SES-CD) - A scale that via colonoscopy of Crohn's disease patients measures: 1.Presence and size of ulcers 2. Extent of ulcerated surface 3. Extent of affected surface and 4. Presence and type of intestinal narrowings. Scale goes from 0 to 56 with a higher score indicating greater severity of disease.
Time Frame
6 months
Title
Assess bacterial markers in stool against colonoscopy scoring system Crohn's Disease Endoscopic Index of Severity (CDEIS)
Description
Identify the correlation of the quantity of specific bacterial markers in the stool as quantified by a stool-based algorithm to the clinical state of the colonoscopy procedure scored by CDEIS tool. 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.
Time Frame
6 months
Title
Assess bacterial markers in stool against disease symptomology scored by Harvey Bradshaw Index (HBI) for clinical evaluation
Description
Determine the correlation of the quantity of specific bacterial markers in the stool as quantified by a stool-based algorithm to the clinical symptoms that measure stool frequency and symptomology by the Harvey Bradshaw Index (HBI) tool. Harvey Bradshaw Index (HBI) - A scale that assesses Crohn's disease patients' signs and symptoms by measuring : 1. General well-being 2. Abdominal pain 3. Number of liquid stools per day 4. Presence of abdominal mass and 5. Complications. Scale goes from 0 to 18 with a higher score indicating greater severity of disease.
Time Frame
6 months
Title
Assess bacterial markers in stool against disease symptomology scored by Crohn's Disease Activity Index (CDAI) for clinical evaluation
Description
Determine the correlation of the quantity of specific bacterial markers in the stool as quantified by a stool-based algorithm to the clinical symptoms that measure stool frequency and symptomology by the Crohn's Disease Activity Index (CDAI) tool. Crohn's Disease Activity Index (CDAI) - A scale that assesses Crohn's disease patients' signs and symptoms by measuring: 1. Number of liquid or soft stools each day for seven days 2. Abdominal pain each day for seven day 3. General well-being, subjectively assessed for day for seven days 4. Presence of complications 5. Taking anti-diarrhea medications 6. Presence of an abdominal mass 7.Hematocrit and 8. Percentage deviation from standard weight. Scale goes from 0 to >600 with a higher score indicating greater severity of disease.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Current ostomy or ileoanal pouch.
Current or previous (of less than 4 weeks prior) participation in in a clinical trial for an investigational drug.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development and Medical Affairs
Organizational Affiliation
Prometheus Laboratories
Official's Role
Study Chair
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Ventura Clinical Trials, LLC.
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Medical Research Center of Connecticut, LLC
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Atlanta Gastroenterology Associates, LLC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Blood and Stool Molecular Biomarkers Longitudinal Detection Study in Crohn's Disease (CD) Patients
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