Identification/Characterization of Changes in Microscopic Colitis

NCT03063957 | Unknown

• 1 other identifier: 2015P001333
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

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.

Conditions

Colitis, Microscopic

Outcome Measures

Primary Outcomes (2)

• Microbiome Analysis

  Standard 16s rRNA sequencing for taxonomic identification and metagenomic profiling of the gut microbiome will be performed on stool and tissue samples.

  1.5 years

• Immune Response

  Immune cells in blood and biopsy samples will be sorted and quantified using flow cytometry

  1.5 years

Secondary Outcomes (1)

• α4β7 in microscopic colitis pathogenesis

  2 years

Study Arms (2)

Microscopic Colitis

Patients with confirmed microscopic colitis

Control

Patients that are not diagnosed with microscopic colitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with suspected or established microscopic colitis who are scheduled to receive a diagnostic colonoscopy or attend an office visit at the MGH Gastroenterology Unit will be eligible for recruitment

You may qualify if:

• Ability to give informed consent
• Ability and willingness to comply with all patient visits and study-related procedures
• Ability to understand and complete all study-related materials and questionnaires
• Patients ages 18 or older with suspected microscopic colitis
• Patients that have been previously treated for microscopic colitis that are being seen for possible relapse will also be included

You may not qualify if:

• Inability to provide informed consent
• Inability or unwillingness to comply with all patient visits and study-related procedures
• Inability to understand and complete all study-related materials and questionnaires
• Patients with a known diagnosis of Inflammatory Bowel Disease or colorectal cancer
• Patients with a known bleeding disorder, acute disease, or those that are awaiting transplantation
• Patients who have taken antibiotics in the last two weeks
• Female subjects who are pregnant or nursing

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Takeda Pharmaceuticals North America, Inc.: collaborator
• American College of Gastroenterology: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (8)

• Brown WR, Tayal S. Microscopic colitis. A review. J Dig Dis. 2013 Jun;14(6):277-81. doi: 10.1111/1751-2980.12046.

  PMID: 23419063 BACKGROUND

• Chande N, MacDonald JK, McDonald JW. Interventions for treating microscopic colitis: a Cochrane Inflammatory Bowel Disease and Functional Bowel Disorders Review Group systematic review of randomized trials. Am J Gastroenterol. 2009 Jan;104(1):235-41; quiz 234, 242. doi: 10.1038/ajg.2008.16.

  PMID: 19098875 BACKGROUND

• Colussi D, Salari B, Stewart KO, Lauwers GY, Richter JR, Chan AT, Ricciardiello L, Khalili H. Clinical characteristics and patterns and predictors of response to therapy in collagenous and lymphocytic colitis. Scand J Gastroenterol. 2015;50(11):1382-8. doi: 10.3109/00365521.2015.1050692. Epub 2015 May 21.

  PMID: 25997458 BACKGROUND

• Jarnerot G, Hertervig E, Granno C, Thorhallsson E, Eriksson S, Tysk C, Hansson I, Bjorknas H, Bohr J, Olesen M, Willen R, Kagevi I, Danielsson A. Familial occurrence of microscopic colitis: a report on five families. Scand J Gastroenterol. 2001 Sep;36(9):959-62. doi: 10.1080/003655201750305486.

  PMID: 11521987 BACKGROUND

• Kao KT, Pedraza BA, McClune AC, Rios DA, Mao YQ, Zuch RH, Kanter MH, Wirio S, Conteas CN. Microscopic colitis: a large retrospective analysis from a health maintenance organization experience. World J Gastroenterol. 2009 Jul 7;15(25):3122-7. doi: 10.3748/wjg.15.3122.

  PMID: 19575491 BACKGROUND

• Khan MA, Brunt EM, Longo WE, Presti ME. Persistent Clostridium difficile colitis: a possible etiology for the development of collagenous colitis. Dig Dis Sci. 2000 May;45(5):998-1001. doi: 10.1023/a:1005593628991. No abstract available.

  PMID: 10795766 BACKGROUND

• LaSala PR, Chodosh AB, Vecchio JA, Schned LM, Blaszyk H. Seasonal pattern of onset in lymphocytic colitis. J Clin Gastroenterol. 2005 Nov-Dec;39(10):891-3. doi: 10.1097/01.mcg.0000180634.84689.c2.

  PMID: 16208113 BACKGROUND

• Yao MD, von Rosenvinge EC, Groden C, Mannon PJ. Multiple endoscopic biopsies in research subjects: safety results from a National Institutes of Health series. Gastrointest Endosc. 2009 Apr;69(4):906-10. doi: 10.1016/j.gie.2008.05.015. Epub 2009 Jan 10.

  PMID: 19136110 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Tissue, blood, stool

MeSH Terms

Conditions

Colitis, Microscopic

Condition Hierarchy (Ancestors)

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

Study Officials

• Hamed Khalili, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hamed Khalili, MD

CONTACT

978-882-6709; hkhalili@partners.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine at Harvard Medical School

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: February 24, 2017
• Study Start: June 30, 2015
• Primary Completion: July 31, 2023
• Study Completion: January 31, 2024
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)