Mind/Body Medicine and IBD Flare-Up

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ali Keshavarzian, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT00568256
First received: December 4, 2007
Last updated: February 24, 2012
Last verified: February 2012
  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.


Condition Intervention Phase
Ulcerative Colitis
Behavioral: Mind/Body Courses
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Mind/Body Medicine and IBD Flare-Up

Resource links provided by NLM:


Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • gut inflammation assessed by stool Calprotectin [ Time Frame: (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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Gut oxidative tissue injury assessed by mucosal protein oxidation (protein carbonyl) [ Time Frame: (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 ] [ Designated as safety issue: No ]
  • stress responses assessed by 24h urinary cortisol and psychological questionnaire [ Time Frame: (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 ] [ Designated as safety issue: No ]
  • prevention of flare-up assessed by IBD-related clinical, endoscopic, and histological indices [ Time Frame: (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 ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: November 2007
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Mind/Body Course
Behavioral: Mind/Body Courses
8-week Mind/Body course held once a week for 2 hours at a time.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00568256

Locations
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Investigators
Principal Investigator: Ali Keshavarzian, M.D. Rush University Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Ali Keshavarzian, Dr. Ali Keshavarzian, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT00568256     History of Changes
Obsolete Identifiers: NCT00571532
Other Study ID Numbers: 07092603
Study First Received: December 4, 2007
Last Updated: February 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Rush University Medical Center:
Ulcerative Colitis
IBD Flare-Up
Stress

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014