Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-01-01 @ 7:21 AM
Study NCT ID:
NCT00568256
Status:
COMPLETED
Last Update Posted:
2012-02-27
First Post:
2007-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mind/Body Medicine and IBD Flare-Up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-24', 'studyFirstSubmitDate': '2007-12-04', 'studyFirstSubmitQcDate': '2007-12-04', 'lastUpdatePostDateStruct': {'date': '2012-02-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'gut inflammation assessed by stool Calprotectin', 'timeFrame': '(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'}], 'secondaryOutcomes': [{'measure': 'Gut oxidative tissue injury assessed by mucosal protein oxidation (protein carbonyl)', 'timeFrame': '(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'}, {'measure': 'stress responses assessed by 24h urinary cortisol and psychological questionnaire', 'timeFrame': '(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'}, {'measure': 'prevention of flare-up assessed by IBD-related clinical, endoscopic, and histological indices', 'timeFrame': '(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'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ulcerative Colitis', 'IBD Flare-Up', 'Stress'], 'conditions': ['Ulcerative Colitis']}, 'referencesModule': {'references': [{'pmid': '24557009', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nHypotheses: Stress causes Ulcerative Colitis flare-up and stress reduction will prevent Ulcerative Colitis flare-up.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of moderately severe Ulcerative Colitis\n* Age 18-70\n* Must have inactive disease at the time of recruitment, with at least one documented disease flare-up within the past 2 years.\n* 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.\n\nExclusion Criteria:\n\n* Active Ulcerative Colitis or daily rectal bleeding for 7 days\n* 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\n* History of colon resection\n* Antibiotics use within the previous 14 days\n* Pregnant or lactating women\n* 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'}, 'identificationModule': {'nctId': 'NCT00568256', 'briefTitle': 'Mind/Body Medicine and IBD Flare-Up', 'nctIdAliases': ['NCT00571532'], 'organization': {'class': 'OTHER', 'fullName': 'Rush University Medical Center'}, 'officialTitle': 'Mind/Body Medicine and IBD Flare-Up', 'orgStudyIdInfo': {'id': '07092603'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Mind/Body Course', 'interventionNames': ['Behavioral: Mind/Body Courses']}, {'type': 'OTHER', 'label': 'Other', 'description': 'Mind/Body Course', 'interventionNames': ['Behavioral: Mind/Body Courses']}], 'interventions': [{'name': 'Mind/Body Courses', 'type': 'BEHAVIORAL', 'description': '8-week Mind/Body course held once a week for 2 hours at a time.', 'armGroupLabels': ['Experimental', 'Other']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Ali Keshavarzian, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rush University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rush University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Ali Keshavarzian', 'investigatorFullName': 'Ali Keshavarzian', 'investigatorAffiliation': 'Rush University Medical Center'}}}}