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

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ClinicalTrials.gov Identifier: NCT04043897
Recruitment Status : Recruiting
First Posted : August 2, 2019
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Eugene F Yen, MD, NorthShore University HealthSystem

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

Condition or disease Intervention/treatment Phase
Microscopic Colitis Drug: Rifaximin 550mg Phase 2

Detailed Description:
This is an open-label single-arm trial to evaluate the efficacy of Rifaximin in patients with active microscopic colitis (MC). 10 subjects will be asked to take 500mg Rifaximin three times per day for 4 weeks. The primary endpoints will be histologic response and clinical remission (less than 3 stools per day and less than 1 watery stool per day within the prior 7 days. The secondary endpoint will be change of the MC Disease Activity Index (MCDAI).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Patients with a diagnosis of microscopic colitis will receive open-label rifaximin 550mg tid x 4 weeks.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Oral Rifaximin in Patients With Active Microscopic Colitis
Actual Study Start Date : June 29, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Rifaximin

Arm Intervention/treatment
Experimental: Drug
Patients will receive open-label rifaximin 550mg tid x 4 weeks.
Drug: Rifaximin 550mg
Rifaximin 550mg




Primary Outcome Measures :
  1. Number of Subject Experiencing Remission of MC Symptoms [ Time Frame: 6 weeks ]
    Remission, which will be define as less than 3 stools per day and less than 1 watery stool per day within the prior 7 days as per Hjortswang criteria, which has been used as the standard definition of remission in most all randomized clinical trials evaluating budesonide and MC. Investigators will also look at number of bowel movements, abdominal pain, incontinence, and nocturnal bowel movements. Symptoms will be compared at Week 0 and Week 6.

  2. Histologic Response for Indications of Disease Severity [ Time Frame: 6 weeks ]
    Our institution has identified histologic parameters associated with more severe disease activity. In collaboration with pathologists, investigators will compare histologic inflammation on patients before and after treatment. Histology will be assessed via standard H&E staining, specifically looking at surface epithelial changes associated with disease severity.


Secondary Outcome Measures :
  1. Change of the MC Disease Activity Index (MCDAI) [ Time Frame: 6 weeks ]

    The MCDAI scale was developed to best predict a patient's quality of life as well as approximate a physician's global assessment. In multivariate analysis, the MCDAI demonstrated four independent clinical features associated with the physician global assessment including the number of unformed stools daily, number of nocturnal stools, abdominal pain, and number of episodes of fecal incontinence. These factors were used to develop estimated regression coefficients as weights produced the MCDAI formula: 1.1+0.31 (average number of unformed stools daily over the past week; continuous variable)+0.78 (nocturnal stools over past week, 0=absent, 1=present)+0.22 (maximum abdominal pain over past week, score 1-10)+0.11 (average weight loss per month (lbs))+0.93 (fecal urgency over past week, 0=absent, 1=present)+0.01 (number of episodes of fecal incontinence over past month; continuous variable).

    This will be assessed at Week 0 and at Week 6.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Collagenous colitis (CC) or lymphocytic colitis (LC) diagnosed on colon biopsies reviewed by 2 separate pathologists
  • 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
  • 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
  • Subjects in active flare, defined as >3 watery/loose stools per day on >4 / 7 days over >4 weeks in the past 3 months.

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04043897


Contacts
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Contact: Clinicl Research Coordinator 847-570-2138 ichiou@northshore.org
Contact: Research Manager 847-570-4208 avanderloo@northshore.org

Locations
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United States, Illinois
NorthShore University HealthSystem Recruiting
Evanston, Illinois, United States, 60201
Contact: Clinical Research Coordinator    847-570-2138    ichiou@northshore.org   
Contact: Clinical Research Coordinator    847-570-3708    kcastro@northshore.org   
Principal Investigator: Eugene Yen, MD         
Sub-Investigator: Nora Joseph, MD         
Sponsors and Collaborators
Eugene F Yen, MD
Investigators
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Principal Investigator: Eugene Yen, MD NorthShore University HealthSystem

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Responsible Party: Eugene F Yen, MD, Clinical Associate Professor of Medicine, NorthShore University HealthSystem
ClinicalTrials.gov Identifier: NCT04043897     History of Changes
Other Study ID Numbers: EH17-360
First Posted: August 2, 2019    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Eugene F Yen, MD, NorthShore University HealthSystem:
Microscopic Colitis
Additional relevant MeSH terms:
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Colitis
Colitis, Microscopic
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Rifaximin
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents