Mind/Body Medicine and IBD Flare-Up

Ulcerative Colitis Clinical Trial

Official title:

Mind/Body Medicine and IBD Flare-Up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00568256
• Other study ID #: 07092603
• Status: Completed
• Phase: Phase 1
• First received: December 4, 2007
• Last updated: February 24, 2012
• Start date: November 2007
• Est. completion date: January 2011

Study information

• Verified date: February 2012
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Other known NCT identifiers

• NCT00571532

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Ulcerative Colitis

Intervention

Behavioral:
• Mind/Body Courses
8-week Mind/Body course held once a week for 2 hours at a time.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

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