Ulcerative Colitis
Conditions
Keywords
Ulcerative Colitis, IBD Flare-Up, Stress
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMind/Body Courses
8-week Mind/Body course held once a week for 2 hours at a time.
Sponsors
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| gut inflammation assessed by stool Calprotectin | (1) initial measurement (2) within 1 month of completion of course (3) 6 months after completion of course (4) 1 year after completion of course |
Secondary
| Measure | Time frame |
|---|---|
| Gut oxidative tissue injury assessed by mucosal protein oxidation (protein carbonyl) | (1) initial measurement (2) within 1 month of completion of course (3) 6 months after completion of course (4) 1 year after completion of course |
| stress responses assessed by 24h urinary cortisol and psychological questionnaire | (1) initial measurement (2) within 1 month of completion of course (3) 6 months after completion of course (4) 1 year after completion of course |
| prevention of flare-up assessed by IBD-related clinical, endoscopic, and histological indices | (1) initial measurement (2) within 1 month of completion of course (3) 6 months after completion of course (4) 1 year after completion of course |
Countries
United States
Outcome results
None listed