Expired Study
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Chicago, Illinois 60612


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - 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. Exclusion Criteria: - 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


NCT ID:

NCT00568256


Primary Contact:

Principal Investigator
Ali Keshavarzian, M.D.
Rush University Medical Center


Backup Contact:

N/A


Location Contact:

Chicago, Illinois 60612
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 17, 2017

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