Mind/Body Medicine and IBD Flare-Up - Full Text View

Sponsored by:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00571532

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.

Condition	Intervention	Phase
Ulcerative Colitis	Behavioral: Mind/Body Course	Phase I

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Ulcerative Colitis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Mind/Body Medicine and IBD Flare-Up

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

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 24th 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 ]

Estimated Enrollment:	100
Study Start Date:	November 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Mind/Body Course	Behavioral: Mind/Body Course 8-week Mind/Body course held once a week for 2 hours at a time
2 Mind/Body Course	Behavioral: Mind/Body Course 8-week Mind/Body course held once a week for 2 hours at a time

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 6 months
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; Remicaid 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
Pts taking disallowed 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 Infleximab 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>3mg/dL), pulmonary disease (shortness of breath at rest or need 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: NCT00571532

Contacts

Contact: Eimile R Dalton, BA	312 942 2845	eimile_r_dalton@rush.edu
Contact: Sharon Jedel, PsyD	312 563 3898	sharon_jedel@rush.edu

Locations

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

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Ali Keshavarzian, M.D.

Rush University Medical Center

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Rush University Medical Center ( Ali Keshavarzian, M.D. )
Study ID Numbers:	R21 AT003939-01A1, 404-0001, 07092603
Study First Received:	December 10, 2007
Last Updated:	August 5, 2008
ClinicalTrials.gov Identifier:	NCT00571532
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

Ulcerative Colitis
IBD Flare-Up
Stress

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Ulcer
Colonic Diseases
Inflammatory Bowel Diseases

Stress
Colitis, Ulcerative
Intestinal Diseases
Gastroenteritis
Colitis

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 13, 2009