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Ulcerative Colitis is an Inflammatory Bowel disease that is a life-long, relapsing disabling disorder. Current treatments for Ulcerative Colitis are not satisfactory. Most medications provide only partial relief, are not successful for at least 30% of patients, and have major negative side effects. Mounting evidence indicates that stress is one of the important triggers that activates symptoms of ulcerative colitis and therefore causes flare-up. The primary aim of this study is to see if either of two 8-week Mind-Body courses has an effect in reducing stress and affecting the course and severity of UC.
Hypotheses: Stress causes Ulcerative Colitis flare-up and stress reduction will prevent Ulcerative Colitis flare-up.
Methods: We will enroll 100 subjects in a Phase I/IIa randomized, double-blind, placebo-controlled trial. Subjects will be assigned to one of two Mind/Body courses, each of which will be held once a week for 8 consecutive weeks. Each class will last 1.5-2 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Mind/Body Course |
|
| Other | Other | Mind/Body Course |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mind/Body Courses | Behavioral | 8-week Mind/Body course held once a week for 2 hours at a time. |
|
| Measure | Description | Time Frame |
|---|---|---|
| gut inflammation assessed by stool Calprotectin | (1) initial measurement (2) within 1 month of completion of course (3) 6 months after completion of course (4) 1 year after completion of course |
| Measure | Description | Time Frame |
|---|---|---|
| Gut oxidative tissue injury assessed by mucosal protein oxidation (protein carbonyl) | (1) initial measurement (2) within 1 month of completion of course (3) 6 months after completion of course (4) 1 year after completion of course | |
| stress responses assessed by 24h urinary cortisol and psychological questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ali Keshavarzian, M.D. | Rush University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24557009 | Derived | Jedel S, Hoffman A, Merriman P, Swanson B, Voigt R, Rajan KB, Shaikh M, Li H, Keshavarzian A. A randomized controlled trial of mindfulness-based stress reduction to prevent flare-up in patients with inactive ulcerative colitis. Digestion. 2014;89(2):142-55. doi: 10.1159/000356316. Epub 2014 Feb 14. |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| (1) initial measurement (2) within 1 month of completion of course (3) 6 months after completion of course (4) 1 year after completion of course |
| prevention of flare-up assessed by IBD-related clinical, endoscopic, and histological indices | (1) initial measurement (2) within 1 month of completion of course (3) 6 months after completion of course (4) 1 year after completion of course |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |