Efficacy and Safety of Oral Rifaximin in Patients With Active Microscopic Colitis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04043897|
Recruitment Status : Recruiting
First Posted : August 2, 2019
Last Update Posted : August 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Microscopic Colitis||Drug: Rifaximin 550mg||Phase 2|
|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)|
|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|
Patients will receive open-label rifaximin 550mg tid x 4 weeks.
Drug: Rifaximin 550mg
- 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.
- 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.
- 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.
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
|Contact: Clinicl Research Coordinatoremail@example.com|
|Contact: Research Managerfirstname.lastname@example.org|
|United States, Illinois|
|NorthShore University HealthSystem||Recruiting|
|Evanston, Illinois, United States, 60201|
|Contact: Clinical Research Coordinator 847-570-2138 email@example.com|
|Contact: Clinical Research Coordinator 847-570-3708 firstname.lastname@example.org|
|Principal Investigator: Eugene Yen, MD|
|Sub-Investigator: Nora Joseph, MD|
|Principal Investigator:||Eugene Yen, MD||NorthShore University HealthSystem|