View Clinical Trial (Medical Research Study)
Mind-Body Medicine and Ulcerative Colitis
| City: |
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Chicago |
| State: |
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Illinois |
| Zip Code: |
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60612 |
| Conditions: |
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Ulcerative Colitis |
| Purpose: |
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Stress has been linked to chronic health problems, particularly diseases involving
inflammation-mediated tissue injury and organ failure. Accordingly, it is not surprising
that mind/body interventions are advocated for treatment of chronic inflammatory diseases.
One such candidate disease is ulcerative colitis (UC) because: (1) UC is a life-long,
relapsing, disabling inflammatory disorder of the intestine that lacks a non-toxic,
efficacious treatment; (2) the therapeutic goal is to improve quality of life by
ameliorating disabling symptoms and preventing disease progression by preventing disease
flare-up, (3) stress triggers UC flare-up by modifying intestinal function and inflammatory
processes, highlighting the potential therapeutic benefit of reducing physiological stress
responses. The purpose of this study is to see if either of two 8-week mind/body medicine
courses has an effect in reducing stress and affecting the course and severity of UC. Both
have been shown to benefit other aspects of health and well-being.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- You have been diagnosed with moderately severe Ulcerative Colitis at the time of your
last flare up
- You experienced at least one flare-up within the last year
- Either no IBD medication or have been on a stable dose of oral 5-ASA products (i.e.
Mesalamine, Sulfasalazine, or Colazol) for at least 3 weeks, immunomodulators
(Imuran, 6MP, Methotrexate)for at least 3 months and biologics (TNF antibody) for at
least 6 months prior to enrollment
- If on maintenance 5-ASA products or immunomodulators and dose changes during the
study, participant agrees to remain on that dose for the study duration
- ACTIVE UC PATIENTS: If on Prednisone the dose must not be more than 20mg/day; you can
be weaned off Prednisone by 5mg/day weekly to 10mg/day weekly to 2.5mg/day weekly
Exclusion Criteria:
- Other forms of colitis, such as Clostridium Difficile Colitis or Indeterminate
Colitis
- Current use of oral steroids within the last 30 days, topical agents (i.e. steroids
or 5-ASA) within the last 14 days
- History of colon resection
- Antibiotic use within the last 14 days
- WOMEN: Cannot be pregnant
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| NCT ID: |
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NCT01491997 |
| Primary Contact: |
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Principal Investigator
Ali Keshavarzian, MD
Rush University Medical Center
Annika Gorenz, M.S.
Phone: 312-942-1181
Email: annika_gorenz@rush.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Chicago, Illinois 60612
United States
Annika Gorenz, M.S.
Phone: 312-942-1181
Email: annika_gorenz@rush.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
| Modifications to this listing: |
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