Functional DyspepsiaIMAGINENCT07772167
Identifying Multidimensional Signatures of Gastric Interoception in Functional Dyspepsia
A study testing Functional magnetic resonance imaging (fMRI) in people with Functional Dyspepsia and Anorexia Nervosa, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study is being conducted to investigate gut-brain communication in individuals with functional dyspepsia and anorexia nervosa. The hope is that what the investigators learn from this study will improve the understanding the conditions better to improve treatments. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Dyspepsia, Anorexia Nervosa
- What is being tested?
- Functional magnetic resonance imaging (fMRI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2026to Mar 2031
- Phase
- Interventional
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Participant Inclusion Criteria--
Functional Dyspepsia Group:
- Males and females; ages 18-65 years
- Rome V functional dyspepsia post-prandial distress syndrome subtype
- Negative upper endoscopy or upper GI series to rule out structural/organic cause for FD
- greater than or equal to 5.5 gut interoceptive awareness score (by VSI awareness subscale)
- Fluent in English
- Willing and able to provide informed consent
- Stable dose for 30 days prior to Visit 1 if on a neuropsychiatric medication (e.g., TCA, SNRI, SSRI mirtazapine, atypical antipsychotic, gabapentin, buspirone, pregabalin)
- No current plans to initiate a new or change dosing on a neuropsychiatric medication within the study period
Anorexia Nervosa Group:
- Males and females; ages 18-65 years
- DSM-5 anorexia restricting-type by the Eating Disorder Module in the Diagnostic Interview for Mood, Anxiety, and OCD and related Neuropsychiatric Disorders (DIAMOND)
- greater than or equal to 5.5 gut interoceptive awareness score (by VSI awareness subscale)
- Fluent in English
- Willing and able to provide informed consent
- Stable dose for 30 days prior to Visit 1 if on an SSRI
- No current plans to initiate a new neuromodulator
- No current plans to initiate a new SSRI or change dosing on an SSRI
Healthy Controls:
- Males and females; ages 18-65 years
- BMI greater than or equal to 18.5 kg/m2
- Fluent in English
- Willing and able to provide informed consent
Participant Exclusion Criteria--
Functional Dyspepsia Group:
- Presence of other conditions that could explain the patient's symptoms by medical chart:
- Pyloric or intestinal obstruction (by EGD, UGI, or Abdominal CT)
- Active H.pylori (by CLO test or stool antigen test)
- Active inflammatory bowel disease
- Eosinophilic gastroenteritis or eosinophilic esophagitis
- Acute renal failure
- Chronic renal failure (serum creatinine >3 mg/dL) and/or on hemodialysis or peritoneal dialysis
- Acute liver failure
- Any acute gastrointestinal process
- Any plausible structural or metabolic causes
- Heartburn as predominant symptom
- History of peptic ulcer
- Symptom resolution with antisecretory therapy (PPI use for other reasons that did not resolve FD symptoms will be allowed)
- Endorses any contraindications to MRI
- Body weight of 450 lbs or greater or BMI of 50 kg/m2 or greater (limit of MRI table)
- Allergy to pineapple (used in the test meal during MRI)
- History of GI tract surgery or any serious medical condition (e.g., cancer)
- Pregnancy/breastfeeding within the last 8 weeks
- Uncontrolled diabetes (indicated by HbA1c greater than or equal to 7%) by chart
- Narcotic analgesics greater than three days per week
- Cannabinoid use greater than three days per week
- Intellectual disability by history
- Illiteracy
- History of weight/shape-based eating disorder including anorexia nervosa by DIAMOND
- Current binge eating by DIAMOND
- Current self-induced vomiting by DIAMOND
- Current laxative or diuretic misuse by DIAMOND
- Current substance/alcohol use disorder within past year by DIAMOND
- Current/history of psychosis by DIAMOND
- Current mania by DIAMOND
- Active suicidal ideation by modified DIAMOND abbreviated suicide module; passive suicidal ideation is allowed
- Inability or unwillingness to consume food by mouth
- Inability to provide informed consent
Anorexia Nervosa Group:
- Diagnosis of chronic gastrointestinal disorder
- Rome V functional dyspepsia
- Endorses any contraindications to MRI
- Body weight of 450 lbs or greater or BMI of 50 kg/m2 or greater (limit of MRI table)
- Allergy to pineapple (used in the test meal during MRI)
- History of GI tract surgery or any serious medical condition (e.g., cancer)
- Pregnancy/breastfeeding within the last 8 weeks
- Uncontrolled diabetes (indicated by HbA1c greater than or equal to 7%) by chart
- Narcotic analgesics greater than three days per week
- Cannabinoid use greater than three days per week
- Intellectual disability by history
- Illiteracy
- Current binge eating by DIAMOND
- Current self-induced vomiting by DIAMOND
- Current laxative or diuretic misuse by DIAMOND
- Current substance/alcohol use disorder within past year by DIAMOND
- Current/history of psychosis by DIAMOND
- Current mania by DIAMOND
- Active suicidal ideation by DIAMOND abbreviated suicide module; passive suicidal ideation is allowed
- Inability or unwillingness to consume food by mouth
- Inability to provide informed consent
- Current use of neuropsychiatric medication other than an SSRI (e.g., TCA, SNRI, mirtazapine, atypical antipsychotic, gabapentin, buspirone, pregabalin)
Healthy Controls:
- Diagnosis of chronic gastrointestinal or pain disorder
- Rome V functional dyspepsia
- greater than or equal to 5.5 gut interoceptive awareness score (by VSI awareness subscale)
- Current use of a medication known to influence gastric sensorimotor functions (including neuromodulators and SSRIs)
- Active psychiatric disorder including a feeding/eating disorder by DIAMOND
- Endorses any contraindications to MRI
- Body weight of 450 lbs or greater or BMI of 50 kg/m2 or greater (limit of MRI table)
- Allergy to pineapple (used in the test meal during MRI)
- History of GI tract surgery or any serious medical condition (e.g., cancer)
- Pregnancy/breastfeeding within the last 8 weeks
- Uncontrolled diabetes (indicated by HbA1c greater than or equal to 7%) by chart
- Narcotic analgesics greater than three days per week
- Cannabinoid use greater than three days per week
- Intellectual disability by history
- Illiteracy
- Current binge eating by DIAMOND
- Current self-induced vomiting by DIAMOND
- Current laxative or diuretic misuse by DIAMOND
- Current substance/alcohol use disorder within past year by DIAMOND
- Current/history of psychosis by DIAMOND
- Current mania by DIAMOND
- Active suicidal ideation by DIAMOND modified suicide module; passive suicidal ideation is allowed
- Inability or unwillingness to consume food by mouth
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
IMAGINE Study Coordinator CRC, 617-643-7884, imaginestudy@mgb.org
About this study
This study is being conducted to investigate gut-brain communication in individuals with functional dyspepsia and anorexia nervosa. The hope is that what the investigators learn from this study will improve the understanding the conditions better to improve treatments.
- Conditions
- Functional Dyspepsia, Anorexia Nervosa
- Being tested
- Functional magnetic resonance imaging (fMRI)
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional magnetic resonance imaging (fMRI)Other
Pineapple pudding snack, with pre- and post-snack fMRI
| Study group | Role | What they receive |
|---|---|---|
| Functional Dyspepsia, Healthy Control, Anorexia Nervosa | Other | Not described Receives: Other: Functional magnetic resonance imaging (fMRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual interoception task
The study team will be investigating brain activity and connectivity during an interoception task. This will be measured via functional magnetic resonance imaging (fMRI) which is able to measure blood flow to regions of the brain.
Measured: Day 1, visit 1, 30-minute scan and visit 2 (within approximately two weeks of day 1), 30-minute scan
Resting state connectivity
Change in brain activity during rest pre and post prandially using functional magnetic resonance imaging (fMRI).
Measured: Visit 2 (second visit, within approximately 2 weeks of day 1 of the study), 60 minute scan.
Gastric peristaltic velocity
MRI-derived gastric motility outcome
Measured: 30 minutes (only in Visit 2, within approximately two weeks of Visit 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start16 Mar 2026
- Primary completionMar 2030 (estimated)
- Study completionMar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helen Burton-Murray, PHD, Massachusetts General Hospital
- Investigators
- Helen Burton-Murray, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772167
- Sponsor's protocol ID
- 2025P001856
- Other IDs
- R01DK145599
- Acronym
- IMAGINE
- Status last verified
- Aug 2026
- First submitted
- 29 Jun 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Multidimensional Signatures of Gastric Interoception in Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT07772167
- Acronym / sponsor ID
- IMAGINE / 2025P001856
- Conditions
- Functional Dyspepsia, Anorexia Nervosa
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Mar 2031 (estimated)
- First posted
- 19 Aug 2026 (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.
This study is being conducted to investigate gut-brain communication in individuals with functional dyspepsia and anorexia nervosa. The hope is that what the investigators learn from this study will improve the understanding the conditions better to improve treatments.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Functional Dyspepsia, Healthy Control, Anorexia Nervosa | Other | Other: Functional magnetic resonance imaging (fMRI) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Functional magnetic resonance imaging (fMRI)Pineapple pudding snack, with pre- and post-snack fMRI | Other | Functional Dyspepsia, Healthy Control, Anorexia Nervosa |
Primary outcome
Visual interoception task
Time frame: Day 1, visit 1, 30-minute scan and visit 2 (within approximately two weeks of day 1), 30-minute scan
The study team will be investigating brain activity and connectivity during an interoception task. This will be measured via functional magnetic resonance imaging (fMRI) which is able to measure blood flow to regions of the brain.
Resting state connectivity
Time frame: Visit 2 (second visit, within approximately 2 weeks of day 1 of the study), 60 minute scan.
Change in brain activity during rest pre and post prandially using functional magnetic resonance imaging (fMRI).
Gastric peristaltic velocity
Time frame: 30 minutes (only in Visit 2, within approximately two weeks of Visit 1)
MRI-derived gastric motility outcome
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 19 Aug 2026.
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Active, not recruitingPhase 1
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Functional Dyspepsia
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Probiotic and Ginger Supplement for Symptoms and Quality of Life in Functional Dyspepsia (SUBTILE)
Functional Dyspepsia
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
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RecruitingPhase 4
Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia
Functional Dyspepsia, Probiotics
RecruitingPhase 2
Exploring Novel Therapeutic Approaches for Disorders of Gut-Liver-Brain Interaction-H1/H2
Functional Gastrointestinal Disorders
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.
Helen Burton-Murray, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional magnetic resonance imaging (fMRI) in people with Functional Dyspepsia and Anorexia Nervosa, run by Massachusetts General Hospital 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?
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: looking for participants now, as of the sponsor's last update on 19 Aug 2026. 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?
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?
Contact Caroline Adams (617-643-7884, imaginestudy@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual interoception task (time frame: Day 1, visit 1, 30-minute scan and visit 2 (within approximately two weeks of day 1), 30-minute scan). 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 19 Aug 2026.