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Risk Factors for Microscopic Colitis

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ClinicalTrials.gov Identifier: NCT02699333
Recruitment Status : Recruiting
First Posted : March 4, 2016
Last Update Posted : December 12, 2019
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
Microscopic colitis is a common cause of watery diarrhea, particularly in the elderly. Although the incidence is comparable to ulcerative colitis and Crohn's disease, the etiology is unknown. Understanding the etiology of microscopic colitis is an important step in developing logical interventions to decrease the burden from microscopic colitis. This research could provide critical insights into the etiology of this poorly studied condition.

Condition or disease
Colitis, Microscopic

Detailed Description:

Microscopic colitis (MC) is a chronic condition that is a common cause of watery diarrhea, particularly in the elderly. The etiology is unknown but widely considered to be an abnormal immune reaction to luminal antigens in predisposed hosts. Drugs and autoimmunity have also been implicated. The aims of the study are: 1) To quantitatively classify microscopic colitis using image analysis microscopy to determine whether the degree of lymphocytic infiltration correlates with etiology, symptoms and prognosis. 2) To investigate the etiology of microscopic colitis by examining medical and lifestyle risk factors including medications, autoimmunity, diet, and smoking 3) To evaluate the association between the adherent microbial flora and MC to assess whether bacterial dysbiosis is linked to presence of MC. As an exploratory aim we will evaluate whether CYP2C19 polymorphisms are more common in purportedly drug-induced disease since the diverse drugs that have been associated with MC are all substrates for this gene.

To conduct the study the investigators will obtain detailed dietary, medical and lifestyle information on study subjects who undergo complete colonoscopy for diarrhea. The investigators will obtain colon biopsies from the right, transverse and left colon to evaluate adherent bacterial organisms. The investigators will draw blood to evaluate CYP2C19 polymorphisms and for future genetic studies. The prospective design corrects important limitations of prior research on MC. Successful completion of the study aims will improve the understanding of risk factors, set the stage for more scientifically grounded future research, and potentially suggest new interventions for a disease that is currently poorly understood.

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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Risk Factors for Microscopic Colitis
Study Start Date : May 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Group/Cohort
Microscopic colitis cases
Patients found to have microscopic colitis based on colonic biopsies.
Controls
Patients who meet eligibility requirements but do not have microscopic colitis on biopsy.



Primary Outcome Measures :
  1. Microscopic Colitis [ Time Frame: Day 1 ]
    Microscopic colitis defined by increased lymphocytes or collagen


Biospecimen Retention:   Samples With DNA

40 ml of blood centrifuged and separated into plasma, buffy coat and red blood cells. A serum separator tube will be used to collect an additional 10 ml of blood for serum.

During colonoscopy, four mucosal biopsies will be obtained from normal appearing mucosa in the ascending colon, transverse colon, and descending/sigmoid colon during the withdrawal phase of the exam from each patient (12 research biopsies). To improve orientation 2 biopsies from each segment will be flattened onto filter paper using a forceps and placed together into fixative. The remaining 2 biopsies from each area will be rinsed in sterile PBS to ensure there is no contamination with fecal bacteria prior to freezing in liquid nitrogen.



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who undergo colonoscopy for diarrhea at the University of North Carolina
Criteria

Inclusion Criteria:

Colonoscopy for diarrhea

Exclusion Criteria:

  1. Fewer than 4 loose bowel movements per day.
  2. Failure to visualize the entire colon to the cecum or preparation less than good or excellent.
  3. Age under 35 years. There will be no upper age limit.
  4. Inability to understand and cooperate with the interview.
  5. Indication for colonoscopy other than diarrhea.
  6. Prior history of inflammatory bowel disease (Crohn's disease or ulcerative colitis).

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): NCT02699333


Contacts
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Contact: Robert S. Sandler, MD 919-966-0090 rsandler@med.unc.edu

Locations
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United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599-7555
Contact: Robert S Sandler, MD    919-966-0090    rsandler@med.unc.edu   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: Robert S. Sandler, MD University of North Carolina, Chapel Hill
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02699333    
Other Study ID Numbers: 14-3156
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Colitis
Colitis, Microscopic
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases