UnknownNot Applicable

Identification/Characterization of Changes in Microscopic Colitis

United States330 participantsStarted 2015-06-30

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Microbiome Analysis

Timeframe: 1.5 years

Immune Response

Timeframe: 1.5 years

Trial details

NCT IDNCT03063957

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-07-31

Contact for this trial

Hamed Khalili, MD

978-882-6709 hkhalili@partners.org

View on ClinicalTrials.gov More Colitis, Microscopic trials