Mind/Body Medicine and IBD Flare-Up

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 Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Behavioral: Mind/Body Courses

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.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Investigators: Principal Investigator: Ali Keshavarzian, M.D., Rush University Medical Center

Publications and helpful links

General Publications

• Jedel S, Hoffman A, Merriman P, Swanson B, Voigt R, Rajan KB, Shaikh M, Li H, Keshavarzian A. A randomized controlled trial of mindfulness-based stress reduction to prevent flare-up in patients with inactive ulcerative colitis. Digestion. 2014;89(2):142-55. doi: 10.1159/000356316. Epub 2014 Feb 14.

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: December 4, 2007
• First Submitted That Met QC Criteria: December 4, 2007
• First Posted (Estimate): December 6, 2007

Study Record Updates

• Last Update Posted (Estimate): February 27, 2012
• Last Update Submitted That Met QC Criteria: February 24, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Stress; Ulcerative Colitis; IBD Flare-Up
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: 07092603