Identifying Multidimensional Signatures of Gastric Interoception in Functional Dyspepsia (IMAGINE)

August 14, 2026 updated by: Helen Burton-Murray, PHD, Massachusetts General Hospital
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Functional Dyspepsia, Healthy Control, Anorexia Nervosa
Other: Functional magnetic resonance imaging (fMRI)
Pineapple pudding snack, with pre- and post-snack fMRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1, visit 1, 30-minute scan and visit 2 (within approximately two weeks of day 1), 30-minute scan
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).
Visit 2 (second visit, within approximately 2 weeks of day 1 of the study), 60 minute scan.
Gastric peristaltic velocity
Time Frame: 30 minutes (only in Visit 2, within approximately two weeks of Visit 1)
MRI-derived gastric motility outcome
30 minutes (only in Visit 2, within approximately two weeks of Visit 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Helen Burton-Murray, PhD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2026

Primary Completion (Estimated)

March 1, 2030

Study Completion (Estimated)

March 1, 2031

Study Registration Dates

First Submitted

June 29, 2026

First Submitted That Met QC Criteria

August 14, 2026

First Posted (Actual)

August 19, 2026

Study Record Updates

Last Update Posted (Actual)

August 19, 2026

Last Update Submitted That Met QC Criteria

August 14, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025P001856
  • R01DK145599 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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