Synergistic Gut-brain Axis Modulation Via Vagal Stimulation and Support Therapy in Functional Dyspepsia
NCT ID: NCT06360900
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2025-10-29
2029-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
TRIPLE
Study Groups
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Sensory device + Skills Building
Sensory device
Sensory vagal nerve stimulation
Skills Building
Skills Building behavioral therapy
Sensory device + Health Education
Sensory device
Sensory vagal nerve stimulation
Health Education
Education of FD condition
Subsensory device + Skills Building
Skills Building
Skills Building behavioral therapy
Subsensory device
Subsensory vagal nerve stimulation
Subsensory device + Health Education
Health Education
Education of FD condition
Subsensory device
Subsensory vagal nerve stimulation
Interventions
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Sensory device
Sensory vagal nerve stimulation
Skills Building
Skills Building behavioral therapy
Health Education
Education of FD condition
Subsensory device
Subsensory vagal nerve stimulation
Eligibility Criteria
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Inclusion Criteria
* Ability to give written consent and participate in behavioral intervention in English
* Willingness to attend weekly treatment sessions over live video, daily self-administered transcutaneous auricular vagus nerve stimulation (taVNS) sessions, and engage in homework during treatment
* Avoidance of alcohol, nicotine, and caffeine for 24 hours prior to study session
* Diagnosis according to the Rome IV criteria for both epigastric pain syndrome and postprandial distress syndrome subtypes
* Stable medical treatment for functional dyspepsia (FD) during 1 month before the study and during the study period
Exclusion Criteria
* Enteral or parenteral feeding
* Previous gastrointestinal surgery, electrolyte disturbances, kidney dysfunction, renal insufficiency, or iron overload disorders
* Estimated Glomerular Filtration Rate (eGFR) \< 60
* Medications that affect gastrointestinal motility in addition to medications or products containing tetrahydrocannabinol (THC) will be stopped at least 7 days prior to the start of the study and for the duration of the study. However, anti-depressants (SSRI's, TCA's) may be allowed in order to reduce the risk of worsening neuropsychiatric disease, though it will be up to the study team and the Principal Investigator whether subjects on anti-depressants will be able to participate in the study
* Intellectual disability by history
* Diabetes, mitochondrial disease, severe autonomic dysfunction, and small fiber polyneuropathy
* No active clinical acupuncture therapy
* Illicit drugs or opioid usage
* History of arrhythmias
* Current pregnancy/breastfeeding
* Contraindications for magnetic resonance imaging (MRI) (implanted ferromagnetic objects, claustrophobia)
* Weight \> 450 lbs. (limit of the MRI table)
* Allergy to pineapple (used in the test meal during MRI)
* Any other condition interfering with study requirements, according to the Investigator
18 Years
65 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Spaulding Rehabilitation Hospital
OTHER
Responsible Party
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Roberta Sclocco
Assistant Professor
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Karen Lin
Role: primary
Other Identifiers
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2024P000849
Identifier Type: -
Identifier Source: org_study_id