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.
- Clinical diagnosis of moderately severe Ulcerative Colitis
- Age 18-70
- Must have inactive disease at the time of recruitment, with at least one documented
disease flare-up within the past 2 years.
- Must be on either no IBD medication or have been on a stable dose of any of the
following medications for the specified amount of time: Mesalamine or Sulfasalazine
for at least 6 weeks; Remicade for at least 10 weeks; Imuran or Mercaptopurine at
stable and unchanged dose for at least 8 weeks.
- Active Ulcerative Colitis or daily rectal bleeding for 7 days
- Taking oral steroids within 30 days of enrollment, topical agents (steroids or 5-ASA)
within 14 days,immunomodulators such as Methotrexate or Imuran/6-MP and Infliximab
within 90 days
- History of colon resection
- Antibiotics use within the previous 14 days
- Pregnant or lactating women
- Significant chronic disorders like severe cardiac disease (NY functional state
score>3), renal disease (creatinine>3 mg/dL), pulmonary disease (shortness of breath
at rest or need for oxygen use), active infection, or other organ system disease
requiring medical visits > 3 times /year