Irritable Bowel SyndromeNCT01602575
Neuroimaging and Biomarkers in Chronic Visceral Pain
A study testing Mindfulness based Stress Reduction Training (MBSR) in people with Irritable Bowel Syndrome, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The purpose of this study is to use functional magnetic resonance imaging (fMRI) to evaluate brain resting state networks, responses to abdominal stimuli and the effect of MBSR Training on these measures. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Mindfulness based Stress Reduction Training (MBSR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to 20 Mar 2018
- Phase
- Interventional
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients must meet the Rome III criteria for IBS and lack red flag symptoms, such as weight loss, bloody stool, and fever. In the setting of clinical uncertainty on the part of the examining gastroenterologist, laboratory testing or prior medical records may be requested.
- Upper gastrointestinal symptoms, ie. dyspepsia or heartburn, are acceptable as long as IBS is their most bothersome symptom complex.
- Subject cannot have completed structured training in MBSR or other mindfulness or meditation.
- Subject cannot be currently practicing MBSR.
- A minimal severity score of 75 on the IBS-SSS at screening will be required to ensure at least mild-moderate symptoms at baseline.
- Literate in English
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- Ambulatory without a need for assistive devices.
- Able to participate in the sitting and mild yoga positions required for the MBSR course.
- Right handed due to importance of laterality in brain imaging analysis
- Not pregnant, nursing or postpartum.
- No metals in body, including ferrous metallic implants and tattoos
- No history of claustrophobia.
- Able to lay still on back for extended period of time ( about 90 minutes).
- if unable to participate in the MRI portion of the study you may be eligible to come to the MBSR classes at no cost if you agree to complete the classes, homework and on-line questionnaires.
Who cannot join
- Planned major medical intervention in the next 6 months (e.g. surgery), or surgery in the past 6 months.
- Presence of a significant and ongoing medical problem that would interfere with participation in the study or testing the study hypotheses (e.g. major heart disease, neurological disorders, inflammatory bowel disease, etc).
- Presence of a major psychiatric diagnosis such as schizophrenia, Bipolar disorder, Post-traumatic Stress Disorder, or Obsessive Compulsive disorder. However, subjects with a history of DSMIV diagnosis of Anxiety or Depression, in whom symptoms are not active will be allowed but noted for post-hoc analysis.
- use of centrally acting medications that will interfere with the neuroimaging testing (e.g. narcotic medications). As in past studies we will allow subjects taking stable doses of antidepressant medications (TCAs, SSRIs, SNRIs) for at least six months prior to study to participate.
- Body Mass Index greater than 30.
- Current or past history of chronic pain syndrome other than IBS in the IBS group (pain >6 months at any location).
- History of gastrointestinal surgery other than uncomplicated appendectomy or cholecystectomy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oppenheimer Center for Neurobiology of Stress
Los Angeles, California, 90095
About this study
Official title: Neuroimaging Biomarkers of Mind-Body Treatment Response in Chronic Visceral Pain
The purpose of this study is to use functional magnetic resonance imaging (fMRI) to evaluate brain resting state networks, responses to abdominal stimuli and the effect of MBSR Training on these measures. The goal of this study is to identify biomarkers of IBS and assess the responsiveness these biomarkers after MBSR Training. A biomarker, or biological marker, is in general a substance or measure used as an indicator of a biological state. It is a characteristic that is measured and evaluated as an indicator of normal biological processes, disease processes, or responses to a therapeutic intervention, in this case MBSR.
Read the detailed description
Irritable bowel syndrome (IBS) is the most common chronic visceral pain disorder ranking among the most common of all persistent pain disorders with prevalence rates of 8-12% of the population.3 Diagnostic criteria for IBS include persistent abdominal pain and/or discomfort associated with changes in bowel habit. In the majority of patients, symptoms of other co-morbid pain conditions, such as epigastric pain (functional dyspepsia), pelvic pain (IC/PBS) and musculoskeletal pain (FM) are reported. Estimates are that >50% of the U.S. workforce experiences some type of pain and 13% lose productive work time due to pain over a 2 week period, leading to over 60 billion dollars per year in lost productivity costs.4 There are no generally agreed upon biomarkers for IBS, and diagnoses are exclusively based on subjective symptom criteria. As with most of the persistent pain disorders, IBS patients and their providers have increasingly embraced a biopsychosocial model incorporating psychological and social factors along with physiologic factors, and this forms the basis for integrative treatment approaches. This multimodal approach often incorporates Mind-Body treatments, and there is a growing literature showing clinical efficacy in IBS for interventions incorporating such Mind-Body approaches as meditation, hypnosis, yoga and cognitive therapy.5 However, there is little understanding of the physiological mechanisms underlying mind-body therapies, and for this reason optimization of the treatments for specific individuals and populations is difficult.
In this project we aim to use neuroimaging based biomarkers of IBS to examine which of these physiological measures show changes specific to a mind-body treatment with previously documented efficacy, Mindfulness Based Stress Reduction Training or MBSR. MBSR was chosen as a target treatment for several reasons: Recent clinical trial data suggests there is efficacy in improving IBS symptoms with MBSR, it has demonstrated prior success with other chronic pain conditions and there is considerable literature on meditation associated brain changes.
The primary Objective is to validate optimal biomarker candidates by assessment of treatment responsiveness in IBS patients following Mindfulness Based Stress Reduction (MBSR). The secondary objectives are to determine the generality of optimal biomarkers from Aim 1 and 2 and look at factors such as sex, age, co-morbid pain or mood symptoms, and/or baseline disease severity as moderators of the performance of candidate biomarkers.
Also, exploratory analyses will be performed to assess the effect of an 8 week MBSR training on measures of disease cognition, quality of life and mood defined by pre and post test scores on the behavioral measures listed in the study methods.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Mindfulness based Stress Reduction Training (MBSR)
- Keywords
- IBS, FMRI, MBSR
- Medical subject headings
- Irritable Bowel Syndrome, Ichthyosis Bullosa of Siemens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness based Stress Reduction Training (MBSR)Behavioural
Also called Spastic colon, Irritable colon, MBSR, Mindfulness Meditation
8 (2 hr) classes weekly of MBSR and required homework of MBSR practice approximately 30 minutes per day.
| Study group | Role | What they receive |
|---|---|---|
| mindfulness treatment | Experimental | Mindfulness based stress reduction is the intervention in this single arm trial Receives: Behavioral: Mindfulness based Stress Reduction Training (MBSR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validate Optimal Biomarker candidates
To validate optimal brain biomarker candidates by assessment of treatment responsiveness in IBS patients following and 8 week course in Mindfulness Based Stress Reduction (MBSR).
Measured: After MBSR training (8 weeks).
Secondary outcomes (1)
Specificity, generality and moderation of biomarker response to MBSR treatment.
Specificity of biomarker response to MBSR measured by changes in selected biomarker candidates correlation w/improvement in mindfulness at end of treatment \& 3-month f/u.
Determine generality of optimal biomarkers via examination of factors such as sex, age, co-morbid pain,mood, and/or baseline disease severity, as moderators of biomarker performance.
Moderation of biomarker performance by symptoms: Disease severity, duration, and comorbid symptoms.
Measured: Post MBSR training at 3 month follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2012 (estimated)
- Study startJan 2013
- Primary completion20 Mar 2016
- Study completion20 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Kirsten Tillisch, MD, University of California, Los Angeles
- Investigators
- Kirsten Tillisch, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01602575
- Sponsor's protocol ID
- R01AT007137
- Other IDs
- R01AT007137
- Status last verified
- May 2018
- First submitted
- 17 May 2012
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Neuroimaging data will be shared after initial analysis and publication at pain.ucla.edu to members of the Pain repository
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging Biomarkers of Mind-Body Treatment Response in Chronic Visceral Pain
- ClinicalTrials.gov ID
- NCT01602575
- Acronym / sponsor ID
- R01AT007137
- Conditions
- Irritable Bowel Syndrome
- Keywords
- IBS, FMRI, MBSR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Jan 2013
- Primary completion
- 20 Mar 2016 (actual)
- Study completion
- 20 Mar 2018 (actual)
- First posted
- 21 May 2012 (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.
The purpose of this study is to use functional magnetic resonance imaging (fMRI) to evaluate brain resting state networks, responses to abdominal stimuli and the effect of MBSR Training on these measures. The goal of this study is to identify biomarkers of IBS and assess the responsiveness these biomarkers after MBSR Training. A biomarker, or biological marker, is in general a substance or measure used as an indicator of a biological state. It is a characteristic that is measured and evaluated as an indicator of normal biological processes, disease processes, or responses to a therapeutic intervention, in this case MBSR.
Detailed description
Irritable bowel syndrome (IBS) is the most common chronic visceral pain disorder ranking among the most common of all persistent pain disorders with prevalence rates of 8-12% of the population.3 Diagnostic criteria for IBS include persistent abdominal pain and/or discomfort associated with changes in bowel habit. In the majority of patients, symptoms of other co-morbid pain conditions, such as epigastric pain (functional dyspepsia), pelvic pain (IC/PBS) and musculoskeletal pain (FM) are reported. Estimates are that >50% of the U.S. workforce experiences some type of pain and 13% lose productive work time due to pain over a 2 week period, leading to over 60 billion dollars per year in lost productivity costs.4 There are no generally agreed upon biomarkers for IBS, and diagnoses are exclusively based on subjective symptom criteria. As with most of the persistent pain disorders, IBS patients and their providers have increasingly embraced a biopsychosocial model incorporating psychological and social factors along with physiologic factors, and this forms the basis for integrative treatment approaches. This multimodal approach often incorporates Mind-Body treatments, and there is a growing literature showing clinical efficacy in IBS for interventions incorporating such Mind-Body approaches as meditation, hypnosis, yoga and cognitive therapy.5 However, there is little understanding of the physiological mechanisms underlying mind-body therapies, and for this reason optimization of the treatments for specific individuals and populations is difficult.
In this project we aim to use neuroimaging based biomarkers of IBS to examine which of these physiological measures show changes specific to a mind-body treatment with previously documented efficacy, Mindfulness Based Stress Reduction Training or MBSR. MBSR was chosen as a target treatment for several reasons: Recent clinical trial data suggests there is efficacy in improving IBS symptoms with MBSR, it has demonstrated prior success with other chronic pain conditions and there is considerable literature on meditation associated brain changes.
The primary Objective is to validate optimal biomarker candidates by assessment of treatment responsiveness in IBS patients following Mindfulness Based Stress Reduction (MBSR). The secondary objectives are to determine the generality of optimal biomarkers from Aim 1 and 2 and look at factors such as sex, age, co-morbid pain or mood symptoms, and/or baseline disease severity as moderators of the performance of candidate biomarkers.
Also, exploratory analyses will be performed to assess the effect of an 8 week MBSR training on measures of disease cognition, quality of life and mood defined by pre and post test scores on the behavioral measures listed in the study methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mindfulness treatment | Experimental | Behavioral: Mindfulness based Stress Reduction Training (MBSR)Mindfulness based stress reduction is the intervention in this single arm trial |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Patients must meet the Rome III criteria for IBS and lack red flag symptoms, such as weight loss, bloody stool, and fever. In the setting of clinical uncertainty on the part of the examining gastroenterologist, laboratory testing or prior medical records may be requested.
- Upper gastrointestinal symptoms, ie. dyspepsia or heartburn, are acceptable as long as IBS is their most bothersome symptom complex.
- Subject cannot have completed structured training in MBSR or other mindfulness or meditation.
- Subject cannot be currently practicing MBSR.
- A minimal severity score of 75 on the IBS-SSS at screening will be required to ensure at least mild-moderate symptoms at baseline.
Key exclusion criteria (7 listed)
- Planned major medical intervention in the next 6 months (e.g. surgery), or surgery in the past 6 months.
- Presence of a significant and ongoing medical problem that would interfere with participation in the study or testing the study hypotheses (e.g. major heart disease, neurological disorders, inflammatory bowel disease, etc).
- Presence of a major psychiatric diagnosis such as schizophrenia, Bipolar disorder, Post-traumatic Stress Disorder, or Obsessive Compulsive disorder. However, subjects with a history of DSMIV diagnosis of Anxiety or Depression, in whom symptoms are not active will be allowed but noted for post-hoc analysis.
- use of centrally acting medications that will interfere with the neuroimaging testing (e.g. narcotic medications). As in past studies we will allow subjects taking stable doses of antidepressant medications (TCAs, SSRIs, SNRIs) for at least six months prior to study to participate.
- Body Mass Index greater than 30.
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 |
|---|---|---|
| Mindfulness based Stress Reduction Training (MBSR)Also: Spastic colon, Irritable colon, MBSR, Mindfulness Meditation8 (2 hr) classes weekly of MBSR and required homework of MBSR practice approximately 30 minutes per day. | Behavioural | mindfulness treatment |
Primary outcome
Validate Optimal Biomarker candidates
Time frame: After MBSR training (8 weeks).
To validate optimal brain biomarker candidates by assessment of treatment responsiveness in IBS patients following and 8 week course in Mindfulness Based Stress Reduction (MBSR).
1 secondary outcome
Specificity, generality and moderation of biomarker response to MBSR treatment.
Time frame: Post MBSR training at 3 month follow up.
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 14 May 2018.
- Individual participant dataSharing planned: Yes. Neuroimaging data will be shared after initial analysis and publication at pain.ucla.edu to members of the Pain repository
Related trials for Irritable Bowel Syndrome
RecruitingObservational study
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A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
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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.
Kirsten Tillisch, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness based Stress Reduction Training (MBSR) in people with Irritable Bowel Syndrome, run by University of California, Los Angeles 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 14 inclusion and 7 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 14 May 2018. 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.
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?
Validate Optimal Biomarker candidates (time frame: After MBSR training (8 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2018.