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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Rush University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 August 19, 2014