Risk Factors for Microscopic Colitis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02699333|
Recruitment Status : Recruiting
First Posted : March 4, 2016
Last Update Posted : December 12, 2019
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||1200 participants|
|Official Title:||Risk Factors for Microscopic Colitis|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2021|
Microscopic colitis cases
Patients found to have microscopic colitis based on colonic biopsies.
Patients who meet eligibility requirements but do not have microscopic colitis on biopsy.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699333
|Contact: Robert S. Sandler, MDemail@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator:||Robert S. Sandler, MD||University of North Carolina, Chapel Hill|