Clinical trial NCT06941545: High Resolution Gastric Mapping and Gastroduodenal Manometry
Official title: An Assessment of Gastrointestinal Function Utilizing High Resolution Gastric Mapping, Gastroduodenal Manometry, and Gastric Emptying Testing With Assessment of Acute Response to Transcutaneous Auricular Vagal Nerve Stimulation.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dyspepsia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2025-04-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Dyspepsia is a common problem attributed to gastric sensorimotor dysfunctions ie, delayed, or less frequently rapid gastric emptying (GE), impaired gastric accommodation, and increased gastric sensation. Therapeutic options manage symptoms, and there is no FDA approved medical therapy for dyspepsia. There is a need for better objective understanding of sensorimotor dysfunction in dyspepsia, as well as noninvasive, efficacious, safe, and inexpensive treatments for dyspepsia.

The purpose of this research is to identify disturbances and characterize phenotypes in patients with functional dyspepsia, and to assess the correlations between symptoms (during the manometry and in daily life), gastric emptying, electrical activity (BSGM), and pressure activity (manometry).


Eligibility criteria: Inclusion Criteria

* Symptoms consistent with functional dyspepsia as defined by the ROME IV criteria for 6 months
* Ability to perform appropriate informed consent

Exclusion Criteria

* Known cardiac arrhythmia or major ECG abnormalities, i.e. cardiac conduction disturbances (2nd or 3rd degree AV block, prolonged QTc interval (\> 460 msec) or bradycardia (\< 45 beats/minute)
* Conditions precluding safe use of taVNS
* Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns
* Use of opioids
* Vulnerable study population
* Pregnant women

Primary outcomes:
measure: Gastrointestinal Antral and Duodenal Contraction Frequency
timeFrame: During gastrointestinal motility study (approx. 8 hours)
measure: Gastrointestinal Antral and Duodenal Contraction Amplitude
timeFrame: During gastrointestinal motility study (approx. 8 hours)
measure: Gastrointestinal Antral and Duodenal Phasic Pressure Activity - Motility Index
timeFrame: During gastrointestinal motility study (approx. 8 hours)
measure: Principal Gastric Frequency
timeFrame: During gastrointestinal motility study (8 hours)
measure: BMI-Adjusted Amplitude
timeFrame: During gastrointestinal motility study (8 hours)
measure: Gastric Alimetry Rhythm Index (TM)
timeFrame: During gastrointestinal motility study (8 hours)
measure: Fed:Fasted Amplitude Ratio
timeFrame: During gastrointestinal motility study (8 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Nicholas R Oblizajek, MD
role: PRINCIPAL_INVESTIGATOR
References: