Mind-Body Medicine and Ulcerative Colitis

Completed · Not applicable

Conditions studied: Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT01491997

Run by

Rush University Medical Center

People needed

57

Starts

2011-08-01

Expected to finish

2017-07-01

Last updated by the study team

2021-01-25

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Rush University Medical Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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