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Identifying Multidimensional Signatures of Gastric Interoception in Functional Dyspepsia

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

⁃ 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

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Caroline Adams
imaginestudy@mgb.org
617-643-7884
Time Frame
Start Date: 2026-03-16
Estimated Completion Date: 2031-03
Participants
Target number of participants: 150
Treatments
Other: Functional Dyspepsia, Healthy Control, Anorexia Nervosa
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov