Risk Factors for Microscopic Colitis

NCT02699333 | Completed

• 1 other identifier: 14-3156
• Study Type: observational
• Target: 346
• Locations: 1 country
• Sites: 1

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.

Conditions

Colitis, Microscopic

Outcome Measures

Primary Outcomes (1)

• Microscopic Colitis

  Microscopic colitis defined by increased lymphocytes or collagen

  Day 1

Study Arms (2)

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.

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who undergo colonoscopy for diarrhea at the University of North Carolina

You may qualify if:

• Colonoscopy for diarrhea

You may not qualify if:

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599-7555, United States

Location

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.

MeSH Terms

Conditions

Colitis, Microscopic

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Robert S. Sandler, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: March 4, 2016
• Study Start: May 1, 2016
• Primary Completion: December 24, 2020
• Study Completion: December 24, 2020
• Last Updated: February 21, 2021

Record last verified: 2021-02

Locations

US (1)