High Resolution Gastric Mapping and Gastroduodenal Manometry
- Conditions
- Dyspepsia
- Registration Number
- NCT06941545
- Lead Sponsor
- Mayo Clinic
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Gastrointestinal Antral and Duodenal Phasic Pressure Activity - Motility Index During gastrointestinal motility study (approx. 8 hours) Composite measure combining frequency and amplitude for overall assessment of motility
Principal Gastric Frequency During gastrointestinal motility study (8 hours) Dominant frequency of gastric waves (cycles per minute)
BMI-Adjusted Amplitude During gastrointestinal motility study (8 hours) Amplitude of the gastric myoelectrical signals adjusted for body mass index
Gastric Alimetry Rhythm Index (TM) During gastrointestinal motility study (8 hours) Concentration of power within the gastric frequency band over time, stability of gastric rhythm
Fed:Fasted Amplitude Ratio During gastrointestinal motility study (8 hours) Ratio compares the amplitude of gastric myoelectrical activity in the fed state to the fasting state, reflecting gastric response to a meal
Gastrointestinal Antral and Duodenal Contraction Frequency During gastrointestinal motility study (approx. 8 hours) Summarized as frequency (number of contractions per minute)
Gastrointestinal Antral and Duodenal Contraction Amplitude During gastrointestinal motility study (approx. 8 hours) Summarized as amplitude (strength of contractions)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States