Irritable Bowel SyndromePMVS-PNCT02693730
Phenotyping IBS: Perceptions and Modulations of Visceral Sensations
An observational study of Irritable Bowel Syndrome and Ulcerative Colitis, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The purpose of this research study is to improve the understanding of irritable bowel syndrome (IBS) and its underlying cause. The investigators will use magnetic resonance imaging (MRI) to observe differences in the brain between people diagnosed with IBS compared to healthy controls and people with ulcerative… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome, Ulcerative Colitis, Inflammatory Bowel Disease
- How many people
- 198 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Jun 2021
- Phase
- Observational
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subject population will be made up of male and female adults between the ages of 18-60 and must fall into one of the following 3 groups: a) irritable bowel syndrome, b) ulcerative colitis, or c) healthy controls. Medical screening will be a physician or a nurse will confirm subject eligibility for the study.Subjects will be recruited from clinics and the community in and around Los Angeles Area.
Who may be able to join
- Meet Rome III criteria for IBS
- No red flag signs (i.e., weight loss, bloody stool, fever, anemia)
- Must have UC diagnosis that is clinically \& histologically confirmed
- If woman of childbearing potential, must be willing to use contraception to avoid pregnancy during the course of the study
- If female, negative urine pregnancy tests at Screening \& MRI Visit
- Willingness to participate in this study as evidenced by signed informed consent form
- ambulatory outpatient (does not depend on wheelchair for mobility)
- English is primary oral and written language
Who cannot join
- Major medical intervention occurring in the next 6 months or in the past 6 months
- Presence of significant and ongoing medical problem interfering with participation
- Presence of major psychiatric diagnosis such as schizophrenia, bipolar disorder, PTSD, or Obsessive Compulsive disorder.
- Use of centrally acting medications that will interfere with neuroimaging testing (opiate analgesics, antidepressants).
- Left handed due to importance of laterality in neuroimaging
- Pregnancy or nursing
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- Claustrophobia, Ferromagnetic Implants, or other problematic issues preventing subject participation in MRI
- Current or past history of chronic pain syndrome other than IBS in the IBS group
- History of gastrointestinal surgery other than uncomplicated appendectomy or cholecystectomy
- Use of investigational drugs, products, or devices within 28 days prior to screen and through study participation
- use of steroids in the last 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Oppenheimer Center for Neurobiology of Stress and Resilience
Los Angeles, California, 90095
About this study
Official title: Perceptions and Modulations of Visceral Sensations
The purpose of this research study is to improve the understanding of irritable bowel syndrome (IBS) and its underlying cause. The investigators will use magnetic resonance imaging (MRI) to observe differences in the brain between people diagnosed with IBS compared to healthy controls and people with ulcerative colitis, a disease group that has already been characterized. By doing this correlative and comparative study, the investigators hope to gain knowledge on IBS in order to keep the field moving in the right direction and becoming one step closer to discovering effective treatments.
Read the detailed description
Despite recent breakthroughs in research, irritable bowel syndrome (IBS) lacks a comprehensive mechanistic characterization. While the symptoms of this gastroenterological disorder have been described, the overall assessment of IBS has not led to sufficient treatment and management plans. By moving away from an over-reliance on a symptom-based approach and shifting towards a mechanism-based approach, investigators will be more knowledgeable as they attempt to address the disease. In order to accomplish this, the investigators will work with different patient subgroups, specifically IBS subjects, healthy controls (HCs), and disease control groups such as ulcerative colitis (UC). This will allow for the comparison of significant genetic, social, biological, and neurological findings between subgroups, which will help investigators grasp the differences present in people who suffer from IBS.
The investigators will approach the study in a couple different ways to characterize IBS in the best possible manner. Blood samples and MRI brain images will be collected so that the genetic and neurological factors associated with IBS can be explored. Given the highly interactive nature of the biological systems within the body, the investigators plan to explore the interaction between the brain and the immune system as well as the brain and the gut. In doing so, specific genes that contribute to IBS, as well as changes in the brain that contribute to or result from IBS, can be further scrutinized.Additionally, the immune system's influence on the brain in IBS patients can be compared to healthy controls or UC. All of this information will contribute to therapeutic studies in the future as investigators continue to develop both diagnostic tools and treatments for IBS patients.
Conducting this study necessitates the use of human subjects for research purposes. In total, the investigators will recruit 120 IBS subjects, 70 age-matched HCs, and 100 UC subjects. During the initial screening visit, the subject will complete a physical examination, a short psychological evaluation (MINI+), a pressure \& heat sensitivity test, a quick blood draw, and a set of questionnaires. In total, this baseline visit will take roughly two hours.
On the second visit, the subject will return to complete more questionnaires and have their brains scanned by an MRI machine. The subject will then be disclosed of MRI safety procedures and once they are cleared, they will undergo a 60 minute scanning session with a certified MRI technician. Once this has been complete, the subject will have completed the study.
IBS female subjects that have indicated they would like to be part of the longitudinal study will return at 3 months, 6 months, 9 months, and 12 months for the same MRI procedure described above, with MR-Spectroscopy being an additional modality. They will also complete a 5 minute online survey every month for 9 months to assess their symptoms.
The Neuroimaging Core at the Center for Neurobiology of Stress will be responsible for all brain imaging analyses in years 4-5. Gene expression profiling assays and all microbiome related studies will occur at the Neuroscience Genomics Core Laboratory and the UCLA Center for Systems Biomedicine in years 4-5 as well.
- Keywords
- Irritable Bowel Syndrome, IBS, Ulcerative Colitis, UC, Inflammatory Bowel Disease, IBD, Healthy Control, HC, Visceral Pain, Gut, Neuroimaging, fMRI, resting state, structural MRI, functional MRI, diffusion tensor imaging, MR Spectroscopy
- Medical subject headings
- Irritable Bowel Syndrome, Colitis, Ulcerative, Inflammatory Bowel Diseases, Visceral Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control | Does not have diagnosis of irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD) and is otherwise healthy and able to participate as defined by the exclusionary criteria. | |
| Irritable Bowel Syndrome (IBS) | Diagnosed with IBS and meets the Rome III criteria, in the absence of red flag signs (i.e., unexplained weight loss, bloody stool, fever, anemia) | |
| Ulcerative Colitis (UC) | Clinically and histologically confirmed diagnosis of ulcerative colitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Classifying patients with IBS and Ulcerative Colitis (UC) based on their brain "signatures" obtained from structural and functional MRI scanning.
Magnetic Resonance Imaging provides investigators with anatomical and functional images of the brain. Analytical neuroimaging tools demonstrate the unique brain properties of subjects in accordance with their conditions, referred to as brain "signatures."
Measured: MRI visit will be 45 min to 1 hour.
Global and regional brain network alterations in IBS.
The architecture and wiring of the brain can be characterized using metrics describing the connectedness of brain regions, global and local network communication and signaling, and the contribution of each region to the network's structural integrity and information flow.
Measured: MRI visit will be 45 min to 1 hour.
Possible biological mediators of observed IBS related brain network alterations
Proposed plausible pathophysiological mechanisms underlying structural and functional brain changes include: 1) Genetic and epigenetic factors; 2) neuroinflammation; 3) growth factor or stress-mediator induced neuroplastic changes; 4) microbiome derived metabolites.
Measured: There will be a screening visit of about 1 hour with a single blood and stool sample; followed by about 40 minutes of on-line questionnaires.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2021
- Study completionJun 2021
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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emeran Mayer, MD, University of California, Los Angeles
- Investigators
- Emeran Mayer, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02693730
- Sponsor's protocol ID
- 2R01DK048351-15A1
- Other IDs
- 2R01DK048351-15A1
- Acronym
- PMVS-P
- Status last verified
- May 2023
- First submitted
- 12 Jan 2016
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: All data will be stripped of identifiers before data sharing
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perceptions and Modulations of Visceral Sensations
- ClinicalTrials.gov ID
- NCT02693730
- Acronym / sponsor ID
- PMVS-P / 2R01DK048351-15A1
- Keywords
- Irritable Bowel Syndrome, IBS, Ulcerative Colitis, UC, Inflammatory Bowel Disease, IBD, Healthy Control, HC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jan 2016
- Primary completion
- Jun 2021 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 29 Feb 2016 (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 research study is to improve the understanding of irritable bowel syndrome (IBS) and its underlying cause. The investigators will use magnetic resonance imaging (MRI) to observe differences in the brain between people diagnosed with IBS compared to healthy controls and people with ulcerative colitis, a disease group that has already been characterized. By doing this correlative and comparative study, the investigators hope to gain knowledge on IBS in order to keep the field moving in the right direction and becoming one step closer to discovering effective treatments.
Detailed description
Despite recent breakthroughs in research, irritable bowel syndrome (IBS) lacks a comprehensive mechanistic characterization. While the symptoms of this gastroenterological disorder have been described, the overall assessment of IBS has not led to sufficient treatment and management plans. By moving away from an over-reliance on a symptom-based approach and shifting towards a mechanism-based approach, investigators will be more knowledgeable as they attempt to address the disease. In order to accomplish this, the investigators will work with different patient subgroups, specifically IBS subjects, healthy controls (HCs), and disease control groups such as ulcerative colitis (UC). This will allow for the comparison of significant genetic, social, biological, and neurological findings between subgroups, which will help investigators grasp the differences present in people who suffer from IBS.
The investigators will approach the study in a couple different ways to characterize IBS in the best possible manner. Blood samples and MRI brain images will be collected so that the genetic and neurological factors associated with IBS can be explored. Given the highly interactive nature of the biological systems within the body, the investigators plan to explore the interaction between the brain and the immune system as well as the brain and the gut. In doing so, specific genes that contribute to IBS, as well as changes in the brain that contribute to or result from IBS, can be further scrutinized.Additionally, the immune system's influence on the brain in IBS patients can be compared to healthy controls or UC. All of this information will contribute to therapeutic studies in the future as investigators continue to develop both diagnostic tools and treatments for IBS patients.
Conducting this study necessitates the use of human subjects for research purposes. In total, the investigators will recruit 120 IBS subjects, 70 age-matched HCs, and 100 UC subjects. During the initial screening visit, the subject will complete a physical examination, a short psychological evaluation (MINI+), a pressure \& heat sensitivity test, a quick blood draw, and a set of questionnaires. In total, this baseline visit will take roughly two hours.
On the second visit, the subject will return to complete more questionnaires and have their brains scanned by an MRI machine. The subject will then be disclosed of MRI safety procedures and once they are cleared, they will undergo a 60 minute scanning session with a certified MRI technician. Once this has been complete, the subject will have completed the study.
IBS female subjects that have indicated they would like to be part of the longitudinal study will return at 3 months, 6 months, 9 months, and 12 months for the same MRI procedure described above, with MR-Spectroscopy being an additional modality. They will also complete a 5 minute online survey every month for 9 months to assess their symptoms.
The Neuroimaging Core at the Center for Neurobiology of Stress will be responsible for all brain imaging analyses in years 4-5. Gene expression profiling assays and all microbiome related studies will occur at the Neuroscience Genomics Core Laboratory and the UCLA Center for Systems Biomedicine in years 4-5 as well.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Control | – | –Does not have diagnosis of irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD) and is otherwise healthy and able to participate as defined by the exclusionary criteria. |
| Irritable Bowel Syndrome (IBS) | – | –Diagnosed with IBS and meets the Rome III criteria, in the absence of red flag signs (i.e., unexplained weight loss, bloody stool, fever, anemia) |
| Ulcerative Colitis (UC) | – | –Clinically and histologically confirmed diagnosis of ulcerative colitis |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subject population will be made up of male and female adults between the ages of 18-60 and must fall into one of the following 3 groups: a) irritable bowel syndrome, b) ulcerative colitis, or c) healthy controls. Medical screening will be a physician or a nurse will confirm subject eligibility for the study.Subjects will be recruited from clinics and the community in and around Los Angeles Area.
Key inclusion criteria (8 listed)
- Meet Rome III criteria for IBS
- No red flag signs (i.e., weight loss, bloody stool, fever, anemia)
- Must have UC diagnosis that is clinically \& histologically confirmed
- If woman of childbearing potential, must be willing to use contraception to avoid pregnancy during the course of the study
- If female, negative urine pregnancy tests at Screening \& MRI Visit
Key exclusion criteria (11 listed)
- Major medical intervention occurring in the next 6 months or in the past 6 months
- Presence of significant and ongoing medical problem interfering with participation
- Presence of major psychiatric diagnosis such as schizophrenia, bipolar disorder, PTSD, or Obsessive Compulsive disorder.
- Use of centrally acting medications that will interfere with neuroimaging testing (opiate analgesics, antidepressants).
- Left handed due to importance of laterality in neuroimaging
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Classifying patients with IBS and Ulcerative Colitis (UC) based on their brain "signatures" obtained from structural and functional MRI scanning.
Time frame: MRI visit will be 45 min to 1 hour.
Magnetic Resonance Imaging provides investigators with anatomical and functional images of the brain. Analytical neuroimaging tools demonstrate the unique brain properties of subjects in accordance with their conditions, referred to as brain "signatures."
Global and regional brain network alterations in IBS.
Time frame: MRI visit will be 45 min to 1 hour.
The architecture and wiring of the brain can be characterized using metrics describing the connectedness of brain regions, global and local network communication and signaling, and the contribution of each region to the network's structural integrity and information flow.
Possible biological mediators of observed IBS related brain network alterations
Time frame: There will be a screening visit of about 1 hour with a single blood and stool sample; followed by about 40 minutes of on-line questionnaires.
Proposed plausible pathophysiological mechanisms underlying structural and functional brain changes include: 1) Genetic and epigenetic factors; 2) neuroinflammation; 3) growth factor or stress-mediator induced neuroplastic changes; 4) microbiome derived metabolites.
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 9 May 2023.
- Oppenheimer family center for Neurobiology of Stress at UCLA websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All data will be stripped of identifiers before data sharing
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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.
Emeran Mayer, 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?
An observational study of Irritable Bowel Syndrome and Ulcerative Colitis, 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 8 inclusion and 11 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 9 May 2023. 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?
Classifying patients with IBS and Ulcerative Colitis (UC) based on their brain "signatures" obtained from structural and functional MRI scanning. (time frame: MRI visit will be 45 min to 1 hour.). The study lists 3 primary outcomes in all. 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 9 May 2023.