Mind/Body Medicine and IBD Flare-Up

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mind/Body Medicine and IBD Flare-Up

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Behavioral: Mind/Body Courses


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Mind/Body Course | Behavioral: Mind/Body Courses<br>* 8-week Mind/Body course held once a week for 2 hours at a time.<br>|
| Other: Other<br>Mind/Body Course | Behavioral: Mind/Body Courses<br>* 8-week Mind/Body course held once a week for 2 hours at a time.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ulcerative Colitis, IBD Flare-Up, Stress