Status:
COMPLETED
Mind-Body Medicine and Ulcerative Colitis
Lead Sponsor:
Rush University Medical Center
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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...
Detailed Description
Statistical Analysis. The investigator will use the biopsychomarkers identified as the highest prediction value to determine the relative accuracy to predict response to the Mindful Intervention (i.e....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT01491997
Start Date
August 1 2011
End Date
July 1 2017
Last Update
January 25 2021
Active Locations (1)
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1
Rush University Medical Center
Chicago, Illinois, United States, 60612