Ulcerative ColitisPhase 1NCT00568256
Mind/Body Medicine and IBD Flare-Up
A Phase 1 study testing Mind/Body Courses in people with Ulcerative Colitis, run by Rush University Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Mind/Body Courses
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Jan 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
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.
Read the 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.
- Conditions
- Ulcerative Colitis
- Being tested
- Mind/Body Courses
- Keywords
- Ulcerative Colitis, IBD Flare-Up, Stress
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind/Body CoursesBehavioural
8-week Mind/Body course held once a week for 2 hours at a time.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Mind/Body Course Receives: Behavioral: Mind/Body Courses |
| Other | Other | Mind/Body Course Receives: Behavioral: Mind/Body Courses |
What is being measured
The primary outcome is the main question the study is designed to answer.
gut inflammation assessed by stool Calprotectin
Measured: (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)
Measured: (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
Measured: (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
Measured: (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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2007 (estimated)
- Study startNov 2007
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Keshavarzian, Rush University Medical Center
- Investigators
- Ali Keshavarzian, M.D., Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00568256
- Sponsor's protocol ID
- 07092603
- Status last verified
- Feb 2012
- First submitted
- 4 Dec 2007
- Last updated
- 27 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24557009
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mind/Body Medicine and IBD Flare-Up
- ClinicalTrials.gov ID
- NCT00568256
- Acronym / sponsor ID
- 07092603
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative Colitis, IBD Flare-Up, Stress
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 6 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Mind/Body CoursesMind/Body Course |
| Other | Other | Behavioral: Mind/Body CoursesMind/Body Course |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mind/Body Courses8-week Mind/Body course held once a week for 2 hours at a time. | Behavioural | Experimental, Other |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2012.
- Derived from this study: PubMed 24557009Jedel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Keshavarzian, M.D. principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mind/Body Courses in people with Ulcerative Colitis, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00568256, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2012.