Mind/Body Medicine and IBD Flare-Up

Rush

Status and phase

Completed

Phase 1

Conditions

Ulcerative Colitis

Treatments

Behavioral: Mind/Body Courses

Study type

Interventional

Funder types

Other

Identifiers

NCT00568256

07092603

Details and patient eligibility

About

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.

Full 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.

Enrollment

55 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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