NCT00568256

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2007

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 4, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 6, 2007

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

February 27, 2012

Status Verified

February 1, 2012

Enrollment Period

3.2 years

First QC Date

December 4, 2007

Last Update Submit

February 24, 2012

Conditions

Ulcerative Colitis

Keywords

Ulcerative ColitisIBD Flare-UpStress

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

Experimental

EXPERIMENTAL

Mind/Body Course

Behavioral: Mind/Body Courses

Other

OTHER

Mind/Body Course

Behavioral: Mind/Body Courses

Interventions

Mind/Body CoursesBEHAVIORAL

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

ExperimentalOther

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

  • 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.

    PMID: 24557009DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Ali Keshavarzian, M.D.

    Rush University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Ali Keshavarzian

Study Record Dates

First Submitted

December 4, 2007

First Posted

December 6, 2007

Study Start

November 1, 2007

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

February 27, 2012

Record last verified: 2012-02

Locations

US(1)