Irritable Bowel SyndromeIBSNCT03370614
Pilot Study of the Physiological Effects of an Integrative Medicine Approach in Irritable Bowel Syndrome
An observational study of Irritable Bowel Syndrome, run by Thomas Jefferson University at 2 sites in United States.
Trial summary
Although underutilized, what is emerging as one of the best ways of evaluating inflammation in the body, particularly in difficult to observe regions, is through the use of Fluorodeoxyglucose (FDG) positron emission tomography (PET). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- IBS Group
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 May 2017to 30 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects will be recruited only if they experience symptoms of IBS.
Who may be able to join
- Age greater than 18 years old.
- Meets the Rome III criteria for IBS: Recurrent abdominal pain or discomfort at least 3 days per month in the last 3 months associated with 2 or more of the following: 1) Improvement with defecation; 2) Onset associated with a change in frequency of stool; 3) Onset associated with a change in form (appearance) of stool.
- Patients have no other pre-existing and active significant gastrointestinal medical, neurological, or psychological disorders as per review by the PI
- Minor, stable health problems that should have no substantial effect on cerebral blood flow will be allowed (i.e. controlled hypertension, medication controlled diabetes) as per review by the PI.
- Patients will be allowed to be taking medications or supplements at the initial intake, but they must be on a stable dose regimen for at least 1 month.
- Able to give informed consent and willing to complete the study.
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- No significant current active medical conditions.
- Stable medical conditions as determined by the PI are allowed.
- No brain or body abnormalities that would affect the acquisition or analysis of the scan.
Who cannot join
- Previous abdominal (bowel) surgery.
- Not continuously taking antioxidants or anti-inflammatory medications ( to be reviewed by the PI.
- No other active medical conditions potentially requiring changes in treatment regimen during the study duration.
- Not pregnant or breast feeding
- Enrollment in active clinical trial/ experimental therapy within the prior 30 days.
- Subject is unable or unwilling to lie still in the scanner (i.e. due to claustrophobia or weight > 350 pounds)
- Subject has metal in their body or other reason that they cannot undergo magnetic resonance imaging.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Thomas Jefferson University, Marcus Institute of Integrative Health Centers
Philadelphia, Pennsylvania, 19107
Thomas Jefferson University, Marcus Institute of Integrative Health Centers
Villanova, Pennsylvania, 19085
About this study
Although underutilized, what is emerging as one of the best ways of evaluating inflammation in the body, particularly in difficult to observe regions, is through the use of Fluorodeoxyglucose (FDG) positron emission tomography (PET). FDG is taken up in the body much like glucose and is particularly taken up in areas of inflammation where there is increased metabolism. Therefore, this technology can be used to assess inflammation, and measure the reduction in inflammation as the result of integrative interventions that target dietary modifications designed to reduce inflammation. With this proposed study, we plan to use FDG PET-MRI technology to develop a more specific and sensitive approach for evaluating areas of inflammation associated with IBS and measuring improvements in that inflammation in response to effective integrative interventions.
Read the detailed description
The typical goal of the integrative medicine approach is to develop an individualized plan to help restore homeostasis to the gastrointestinal system targeting a reduction in inflammation as an important element in helping to relieve symptoms. One of the most problematic issues though is to determine where in the GI tract the inflammation is occurring and then evaluating improvements in inflammation as any intervention proceeds.
Participants will undergo a small battery of diagnostic tests that include magnetic resonance imaging (MRI), fluorodeoxyglucose positron emission tomography (FDG-PET). A secondary goal of this study is to evaluate the utility of FDG PET-MRI for assessing reductions in inflammation in patients managed with an integrative medicine approach based upon diet and nutritional counselling.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- IBS Group, Healthy Control Group
- Keywords
- PET, MRI, Irritable Bowel Syndrome, Irritable Bowel, Positron emission tomography, Magnetic resonance imaging, FDG, Fluorodeoxyglucose
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBS GroupOther
Participants will receive approximately 2 months of dietary and nutritional counseling.
Healthy Control GroupOther
Participants will not receive any dietary or nutritional counseling.
| Study group | Role | What they receive |
|---|---|---|
| IBS Group | Participants will complete initial baseline and follow up IBS evaluations and questionnaires. Pre and Post FDG-PET-MR scans will be conducted to evaluate changes at baseline and approximately 2 months after dietary and nutritional counseling. Receives: Other: IBS Group | |
| Healthy Control Group | Participants will complete initial baseline evaluations and questionnaires. Participants will also receive a FDG-PET-MR scan. Receives: Other: Healthy Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined PET/MRI to define IBS activity and inflammation pattern.
To use PET-MRI to define abnormal brain and body activity and evaluate changes in inflammation for IBS patients.
Measured: Baseline and 2 months
Secondary outcomes (1)
Use combined PET/MRI to demonstrate brain and body activity in responders and non-responders.
Patterns will be compared between those who respond and those who do not respond to dietary/nutritional program.
Measured: Baseline and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start4 May 2017
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
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 Thomas Jefferson UniversityThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew B. Newberg, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03370614
- Sponsor's protocol ID
- 17D.184
- Acronym
- IBS
- Status last verified
- Nov 2024
- First submitted
- 7 Dec 2017
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Physiological Effects of an Integrative Medicine Approach in Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT03370614
- Acronym / sponsor ID
- IBS / 17D.184
- Conditions
- Irritable Bowel Syndrome
- Keywords
- PET, MRI, Irritable Bowel Syndrome, Irritable Bowel, Positron emission tomography, Magnetic resonance imaging, FDG, Fluorodeoxyglucose
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 4 May 2017 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 12 Dec 2017 (actual)
- 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.
Although underutilized, what is emerging as one of the best ways of evaluating inflammation in the body, particularly in difficult to observe regions, is through the use of Fluorodeoxyglucose (FDG) positron emission tomography (PET). FDG is taken up in the body much like glucose and is particularly taken up in areas of inflammation where there is increased metabolism. Therefore, this technology can be used to assess inflammation, and measure the reduction in inflammation as the result of integrative interventions that target dietary modifications designed to reduce inflammation. With this proposed study, we plan to use FDG PET-MRI technology to develop a more specific and sensitive approach for evaluating areas of inflammation associated with IBS and measuring improvements in that inflammation in response to effective integrative interventions.
Detailed description
The typical goal of the integrative medicine approach is to develop an individualized plan to help restore homeostasis to the gastrointestinal system targeting a reduction in inflammation as an important element in helping to relieve symptoms. One of the most problematic issues though is to determine where in the GI tract the inflammation is occurring and then evaluating improvements in inflammation as any intervention proceeds.
Participants will undergo a small battery of diagnostic tests that include magnetic resonance imaging (MRI), fluorodeoxyglucose positron emission tomography (FDG-PET). A secondary goal of this study is to evaluate the utility of FDG PET-MRI for assessing reductions in inflammation in patients managed with an integrative medicine approach based upon diet and nutritional counselling.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBS Group | – | Other: IBS GroupParticipants will complete initial baseline and follow up IBS evaluations and questionnaires. Pre and Post FDG-PET-MR scans will be conducted to evaluate changes at baseline and approximately 2 months after dietary and nutritional counseling. |
| Healthy Control Group | – | Other: Healthy Control GroupParticipants will complete initial baseline evaluations and questionnaires. Participants will also receive a FDG-PET-MR scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited only if they experience symptoms of IBS.
Key inclusion criteria (9 listed)
- Age greater than 18 years old.
- Meets the Rome III criteria for IBS: Recurrent abdominal pain or discomfort at least 3 days per month in the last 3 months associated with 2 or more of the following: 1) Improvement with defecation; 2) Onset associated with a change in frequency of stool; 3) Onset associated with a change in form (appearance) of stool.
- Patients have no other pre-existing and active significant gastrointestinal medical, neurological, or psychological disorders as per review by the PI
- Minor, stable health problems that should have no substantial effect on cerebral blood flow will be allowed (i.e. controlled hypertension, medication controlled diabetes) as per review by the PI.
- Patients will be allowed to be taking medications or supplements at the initial intake, but they must be on a stable dose regimen for at least 1 month.
Key exclusion criteria (7 listed)
- Previous abdominal (bowel) surgery.
- Not continuously taking antioxidants or anti-inflammatory medications ( to be reviewed by the PI.
- No other active medical conditions potentially requiring changes in treatment regimen during the study duration.
- Not pregnant or breast feeding
- Enrollment in active clinical trial/ experimental therapy within the prior 30 days.
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 |
|---|---|---|
| IBS GroupParticipants will receive approximately 2 months of dietary and nutritional counseling. | Other | IBS Group |
| Healthy Control GroupParticipants will not receive any dietary or nutritional counseling. | Other | Healthy Control Group |
Primary outcome
Combined PET/MRI to define IBS activity and inflammation pattern.
Time frame: Baseline and 2 months
To use PET-MRI to define abnormal brain and body activity and evaluate changes in inflammation for IBS patients.
1 secondary outcome
Use combined PET/MRI to demonstrate brain and body activity in responders and non-responders.
Time frame: Baseline and 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Andrew B. Newberg, MD principal investigator
Thomas Jefferson University
2 sites 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, run by Thomas Jefferson University at 2 sites 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 9 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: under way, not looking for participants, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Combined PET/MRI to define IBS activity and inflammation pattern. (time frame: Baseline and 2 months). 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 29 Nov 2024.