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Synergistic Gut-brain Axis Modulation Via Vagal Stimulation and Support Therapy in Functional Dyspepsia

NCT06360900 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-11-06

No results posted yet for this study

Summary

The study aims at evaluating physiological and patient-reported outcomes for a dual intervention approach including a stimulation device and support therapy in patients with functional dyspepsia.

Conditions

  • Functional Dyspepsia

Interventions

DEVICE

Sensory device

Sensory vagal nerve stimulation

BEHAVIORAL

Skills Building

Skills Building behavioral therapy

BEHAVIORAL

Health Education

Education of FD condition

DEVICE

Subsensory device

Subsensory vagal nerve stimulation

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Spaulding Rehabilitation Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-29
Primary Completion
2029-03-31
Completion
2029-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06360900 on ClinicalTrials.gov