RECRUITING

Efficacy and Safety of Oral Rifaximin in Patients With Active Microscopic Colitis

Talk to us

Conditions

Microscopic Colitis

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is an open label study looking at rifaximin therapy for the treatment of microscopic (collagenous or lymphocytic) colitis.

Official Title

Efficacy and Safety of Oral Rifaximin in Patients With Active Microscopic Colitis

Quick Facts

Study Start:2018-06-29
Study Completion:2021-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04043897

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Collagenous colitis (CC) or lymphocytic colitis (LC) diagnosed on colon biopsies reviewed by 2 separate pathologists
  2. * CC will be defined histologically to be the following: thickness of the collagenous subepithelial table \>10 micrometer using an ocular micrometer, inflammation in the lamina propria consisting of mainly lymphocytes and plasma cells, lack of crypt architectural distortion, and regenerative-appearing changes in the surface and/or crypt epithelium
  3. * LC will be defined histologically to be the following: intraepithelial lymphocytes \>20 per 100 epithelial cells in the subjective area of highest lymphocyte density, inflammation in the lamina propria consisting of mainly lymphocytes and plasma cells, and regenerative-appearing changes in the surface and/or crypt epithelium
  4. * Subjects in active flare, defined as \>3 watery/loose stools per day on \>4 / 7 days over \>4 weeks in the past 3 months.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Daniel Amusin, BS
CONTACT
847-570-3558
damusin@northshore.org
Iris Chiou, BA
CONTACT
847-570-2138
ichiou@northshore.org

Principal Investigator

Eugene Yen, MD
PRINCIPAL_INVESTIGATOR
NorthShore University HealthSystem

Study Locations (Sites)

NorthShore University HealthSystem
Evanston, Illinois, 60201
United States

Collaborators and Investigators

Sponsor: Eugene F Yen, MD

  • Eugene Yen, MD, PRINCIPAL_INVESTIGATOR, NorthShore University HealthSystem

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-06-29
Study Completion Date2021-12

Study Record Updates

Study Start Date2018-06-29
Study Completion Date2021-12

Terms related to this study

Keywords Provided by Researchers

  • Microscopic Colitis

Additional Relevant MeSH Terms

  • Microscopic Colitis