Mind/Body Medicine and IBD Flare-Up

Completed · Phase 1

Conditions studied: Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT00568256

Run by

Rush University Medical Center

People needed

55

Starts

2007-11-01

Expected to finish

2011-01-01

Last updated by the study team

2012-02-27

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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