NCT07772167

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
53mo left

Started Mar 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress11%
Mar 2026Mar 2031

Study Start

First participant enrolled

March 16, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 19, 2026

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2031

Last Updated

August 19, 2026

Status Verified

August 1, 2026

Enrollment Period

4 years

First QC Date

June 29, 2026

Last Update Submit

August 14, 2026

Conditions

Functional DyspepsiaAnorexia Nervosa

Outcome Measures

Primary Outcomes (3)

  • 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.

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

  • Resting state connectivity

    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

    MRI-derived gastric motility outcome

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

Study Arms (1)

Functional Dyspepsia, Healthy Control, Anorexia Nervosa

OTHER
Other: Functional magnetic resonance imaging (fMRI)

Interventions

Functional magnetic resonance imaging (fMRI)OTHER

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

Functional Dyspepsia, Healthy Control, Anorexia Nervosa

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +8 more criteria

You may not qualify if:

  • 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
  • +67 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

  • Helen Burton-Murray, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Adams

CONTACT

617-643-7884imaginestudy@mgb.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Psychologist

Study Record Dates

First Submitted

June 29, 2026

First Posted

August 19, 2026

Study Start

March 16, 2026

Primary Completion (Estimated)

March 1, 2030

Study Completion (Estimated)

March 1, 2031

Last Updated

August 19, 2026

Record last verified: 2026-08

Locations

US(1)