ClinicalTrials.gg
RecruitingNCT07772167IMAGINEUpdated Aug 19, 2026

Identifying Multidimensional Signatures of Gastric Interoception in Functional Dyspepsia

An interventional study of Functional magnetic resonance imaging (fMRI) in Functional Dyspepsia and Anorexia Nervosa, sponsored by Massachusetts General Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Mar 2026, registered Jun 2026).
  • Started Mar 2026; still recruiting 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 16 studies in Anorexia Nervosa by Massachusetts General Hospital — 2 open to participants now, 2 under way, none of them phase 3. Anorexia Nervosa · Massachusetts General Hospital.

Planned enrollment
Largest of 15
150 · median 40
Started
2026
the only one that year
No phase
3 of 16
2 open now
Registered
16th of 16
by date

Among the 16 studies in Anorexia Nervosa by Massachusetts General Hospital, this one has the largest planned enrollment of the 15 interventional ones, is the only one that started in 2026, is one of 3 with no phase, and was the 16th registered.

By phase

16 studies; the count open now beside each. This study's row is marked.

Phase 27 · 0 open
No phasethis study3 · 2 open
Phase 2/32 · 0 open
Phase 32 · 0 open
Observational1 · 0 open
Phase 1/21 · 0 open

By the year they started

First in 2003; this study’s year is marked. 1 started in 2026.

Size and results

Median enrollment 40 across the 15 interventional studies, 61 across the 1 observational. Of the 13 that completed or were terminated, 11 (85%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 16 studies in Anorexia Nervosa by Massachusetts General Hospital, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Functional Dyspepsia
  • Anorexia Nervosa

Browse trials for

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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
  • 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
  • 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
  • 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 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 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
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Other
    Functional Dyspepsia, Healthy Control, Anorexia Nervosa

    Other: Functional magnetic resonance imaging (fMRI)

Interventions

  • OtherFunctional magnetic resonance imaging (fMRI)

    Pineapple pudding snack, with pre- and post-snack fMRI

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 1, visit 1, 30-minute scan and visit 2 (within approximately two weeks of day 1), 30-minute scan

  2. Resting state connectivity

    Change in brain activity during rest pre and post prandially using functional magnetic resonance imaging (fMRI).

    Time frame: Visit 2 (second visit, within approximately 2 weeks of day 1 of the study), 60 minute scan.

  3. Gastric peristaltic velocity

    MRI-derived gastric motility outcome

    Time frame: 30 minutes (only in Visit 2, within approximately two weeks of Visit 1)

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2026 (actual). Primary completion is estimated for Mar 2030, 48 months after the start.

Of 151 non-industry interventional studies with no phase under Anorexia Nervosa, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 63. This study's planned 48 months is above that.

Counting every sponsor, half of 151 studies reached it within 43 months; a quarter within 24 and three quarters within 63.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 29, 2026
First posted
Aug 19, 2026
StartActual
Mar 16, 2026
Primary completionEst.
Mar 2030
CompletionEst.
Mar 2031
Last update
Aug 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07772167
Responsible party
Helen Burton-Murray, PHD (Clinical Psychologist, Massachusetts General Hospital) — Principal investigator
First posted
Aug 19, 2026
Start date
Mar 16, 2026
Primary completion
Mar 2030 (estimated)
Completion
Mar 2031 (estimated)
Last update
Aug 19, 2026

Study contacts

Caroline Adams
Contact
imaginestudy@mgb.org
617-643-7884
Helen Burton-Murray, PhD
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion