Clinical Trial: Identification/Characterization of Changes in Microscopic Colitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Identification and Characterization of Microbial and Immunologic Changes in Microscopic Colitis

Brief Summary: The goal of this study is to establish a prospective observational cohort of adult patients with microscopic colitis and collect clinical information and specimens over the course of their treatment. This information will be used in order to establish a patient registry with detailed clinical data and a specimen repository for future research as well as to specifically identify genetic and molecular characteristics associated with microscopic colitis.

Detailed Summary:

Microscopic colitis (MC) is a chronic relapsing disease of the colon, characterized by watery non-bloody diarrhea, usually normal colonoscopic findings, and typical histology findings. It is frequently accompanied by abdominal pain, nocturnal diarrhea, and mild weight loss. The incidence of MC has increased significantly over recent years with a 2010 study reporting U.S. incidence for MC as 19.7 per 100,000 person-years. MC comprises two major histological subtypes: collagenous colitis (CC), characterized by a distinctive thickened band of subepithelial collagen (>10-20um), and lymphocytic colitis (LC), with an increased number of intraepithelial lymphocytes (>20 lymphocytes per 100 epithelial cells).

Although the exact etiology of MC remains largely unknown, a few observational studies have suggested associations with autoimmune disorders (e.g. celiac disease, and thyroid disorders), cigarette smoking status, and medications such as non-steroidal anti-inflammatory drugs (NSAIDS), proton pump inhibitors (PPIs), selective serotonin reuptake inhibitors (SSRI), and statins. In addition to environmental factors, recently studies indicate that genetics and specific infectious organisms may also play a role in development of the disease. A recent study revealed a seasonal incidence pattern of lymphocytic colitis, suggesting a potential link to an infectious or allergic component. Further, one study demonstrated an association between collagenous colitis and persistent colonic C. difficile infection. Additionally, while familial occurrence of MC has been reported, suggesting a genetic predisposition, the roles of specific genetic factors have not been described. Finally, recent studies demonstrate an association between MC and various autoimmune disorders including celiac disease, autoimmune thyroid disease, and Sjören's syndrome, indicating that MC may be part of a b
Sponsor: Massachusetts General Hospital

Current Primary Outcome:

  • Microbiome Analysis [ Time Frame: 1.5 years ]
    Standard 16s rRNA sequencing for taxonomic identification and metagenomic profiling of the gut microbiome will be performed on stool and tissue samples.
  • Immune Response [ Time Frame: 1.5 years ]
    Immune cells in blood and biopsy samples will be sorted and quantified using flow cytometry


Original Primary Outcome: Same as current

Current Secondary Outcome: α4β7 in microscopic colitis pathogenesis [ Time Frame: 2 years ]

Vedolizumab will be used as a reagent for in vitro identification and investigation of eosinophils that express α4β7


Original Secondary Outcome: Same as current

Information By: Massachusetts General Hospital

Dates:
Date Received: February 21, 2017
Date Started: June 30, 2015
Date Completion: February 28, 2019
Last Updated: February 21, 2017
Last Verified: February 2017