NCT07772167 Identifying Multidimensional Signatures of Gastric Interoception in Functional Dyspepsia
| NCT ID | NCT07772167 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Functional Dyspepsia |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-03-16 |
| Primary Completion | 2030-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2026-03-16 with a primary completion date of 2030-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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 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
Contact & Investigator
Helen Burton-Murray, PhD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT07772167 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Functional Dyspepsia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07772167 currently recruiting?
Yes, NCT07772167 is actively recruiting participants. Contact the research team at imaginestudy@mgb.org for enrollment information.
Where is the NCT07772167 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT07772167 clinical trial?
NCT07772167 is sponsored by Massachusetts General Hospital. The principal investigator is Helen Burton-Murray, PhD at Massachusetts General Hospital. The trial plans to enroll 150 participants.