Identifying Signatures of Gut Interoception in Functional Dyspepsia and Anorexia Nervosa
Official title: Identifying Multidimensional Signatures of Gastric Interoception in Functional Dyspepsia
Run by Massachusetts General Hospital · NCT07772167 · Data updated 2026-11-12
This study tests how the gut-brain connection works in people with functional dyspepsia or anorexia nervosa using brain imaging.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | March 16, 2026 |
| Main results expected | March 2030 |
| Study ends | March 2031 |
| Registry record updated | August 19, 2026 |
| Trial ID | NCT07772167 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18-65 with Rome V functional dyspepsia post-prandial distress syndrome or DSM-5 anorexia restricting-type, who meet imaging and health criteria and can consent.
✕Probably not a fit
Patients with other GI disorders, non-restricting anorexia nervosa, or unstable neuropsychiatric medication plans may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study uses functional MRI to explore multisystem brain-gut signaling in adults with functional dyspepsia or anorexia nervosa. Participants undergo imaging to identify patterns of gut interoception and how they relate to symptoms. The goal is to deepen understanding of these conditions and inform future treatments. Eligibility includes age 18-65, specific diagnostic criteria, and health screenings to rule out other causes. The study is led by Massachusetts General Hospital with NIDDK collaboration and is located at MGH in Boston.
Why it matters
Potential benefit: If successful, the findings could improve how these conditions are understood and potentially guide new treatment approaches.
How similar studies have gone: Prior brain-imaging studies have shown brain-gut signal patterns in GI and eating disorders, supporting this approach, though specific signatures for these conditions are still being explored.
Who can join: the full rules
Show full inclusion / exclusion 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 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
Where it's running
-
Massachusetts General Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Helen Burton-Murray, PhD — Massachusetts General Hospital
- Study coordinator: Caroline Adams
- Email: imaginestudy@mgb.org
- Phone: 617-643-7884
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.