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

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ClinicalTrials.gov Identifier: NCT03566407
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Prometheus Laboratories

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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Procedure: Colonoscopy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 285 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All study subjects will undergo a protocol required 6 month colonoscopy
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Blood and Stool Molecular Biomarkers Longitudinal Detection Study in Crohn's Disease (CD) Patients
Actual Study Start Date : May 4, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Single Group
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.
Procedure: Colonoscopy
Colonoscopy will be required for all subjects at 6 months - Visit 3.




Primary Outcome Measures :
  1. Assess disease status biomarkers against colonoscopy [ Time Frame: 6 months ]
    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.

  2. 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 Outcome Measures :
  1. Assess bacterial markers in stool against colonoscopy scoring system Simple Endoscopic Score for Crohn's Disease (SES-CD) [ Time Frame: 6 months ]
    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.

  2. Assess bacterial markers in stool against colonoscopy scoring system Crohn's Disease Endoscopic Index of Severity (CDEIS) [ Time Frame: 6 months ]
    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.

  3. Assess bacterial markers in stool against disease symptomology scored by Harvey Bradshaw Index (HBI) for clinical evaluation [ Time Frame: 6 months ]
    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.

  4. Assess bacterial markers in stool against disease symptomology scored by Crohn's Disease Activity Index (CDAI) for clinical evaluation [ Time Frame: 6 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03566407


Contacts
Contact: Clinical Study Manager 858 587 4107 bayda.bahur@prometheuslabs.com

Locations
United States, Connecticut
Medical Research Center of Connecticut, LLC Recruiting
Hamden, Connecticut, United States, 06518
Contact: Study Coordinator         
Principal Investigator: Philip Ginsburg, MD         
United States, Georgia
Atlanta Gastroenterology Associates, LLC Recruiting
Atlanta, Georgia, United States, 30309
Contact: Study Coordinator         
Principal Investigator: Douglas Wolf, MD         
United States, Louisiana
Gastroenterology Associates, LLC Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: Study Coordinator         
Principal Investigator: Jonathon C Chapman, MD         
United States, Massachusetts
Commonwealth Clinical Studies Recruiting
Brockton, Massachusetts, United States, 02302
Contact: Study Coordinator         
Principal Investigator: Jerry Stern, MD         
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Study Coordinator         
Principal Investigator: Andres Yarur, MD         
Sponsors and Collaborators
Prometheus Laboratories
Investigators
Study Chair: Clinical Development and Medical Affairs Prometheus Laboratories

Responsible Party: Prometheus Laboratories
ClinicalTrials.gov Identifier: NCT03566407     History of Changes
Other Study ID Numbers: 17IBD01
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases