Identifying Multidimensional Signatures of Gastric Interoception in Functional Dyspepsia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMassachusetts General Hospital
About this trial
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
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Functional magnetic resonance imaging (fMRI)
Other interventionPineapple pudding snack, with pre- and post-snack fMRI
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Functional Dyspepsia, Healthy Control, Anorexia NervosaOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Day 1, visit 1, 30-minute scan and visit 2 (within approximately two weeks of day 1), 30-minute scan2
Resting state connectivity
Change in brain activity during rest pre and post prandially using functional magnetic resonance imaging (fMRI).
Time frame
Visit 2 (second visit, within approximately 2 weeks of day 1 of the study), 60 minute scan.3
Gastric peristaltic velocity
MRI-derived gastric motility outcome
Time frame
30 minutes (only in Visit 2, within approximately two weeks of Visit 1)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov