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This is an open label study looking at rifaximin therapy for the treatment of microscopic (collagenous or lymphocytic) colitis.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug | Experimental | Patients will receive open-label rifaximin 550mg tid x 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifaximin 550mg | Drug | Rifaximin 550mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subject Experiencing Remission of MC Symptoms | 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. | 6 weeks |
| Histologic Response for Indications of Disease Severity | 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. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of the MC Disease Activity Index (MCDAI) | 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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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel Amusin, BS | Contact | 847-570-3558 | damusin@northshore.org | |
| Iris Chiou, BA | Contact | 847-570-2138 | ichiou@northshore.org |
| Name | Affiliation | Role |
|---|---|---|
| Eugene Yen, MD | Endeavor Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NorthShore University HealthSystem | Recruiting | Evanston | Illinois | 60201 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 4, 2022 | Oct 28, 2022 | 3 |
| ID | Term |
|---|---|
| D046728 | Colitis, Microscopic |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000078262 | Rifaximin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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Patients with a diagnosis of microscopic colitis will receive open-label rifaximin 550mg tid x 4 weeks.
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| 6 weeks |
| D003108 |
| Colonic Diseases |
| D007410 | Intestinal Diseases |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |