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High Resolution Gastric Mapping and Gastroduodenal Manometry

ConditionDyspepsia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMayo Clinic

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Symptoms consistent with functional dyspepsia as defined by the ROME IV criteria for 6 months

Ability to perform appropriate informed consent

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Alimetry

    Device

    High resolution gastric mapping of electrical gastric activity.

  • tVNS

    Device

    Transcutaneous Auricular Vagal Nerve Stimulation, electrical stimulation to the ear.

  • Gastroduodenal Manometry

    Device

    Pressure catheter evaluating gastric and duodenal pressure profiles at rest and with certain stimuli applied

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Dyspeptic Patients undergoing clinically indicated gastroduodenal manometry studyExperimental treatment 3 interventions
Group B: Dyspeptic patients not undergoing GDM, tested with body surface gastric mapping aloneExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Gastrointestinal Antral and Duodenal Contraction Frequency

Summarized as frequency (number of contractions per minute)

Time frame
During gastrointestinal motility study (approx. 8 hours)
2

Gastrointestinal Antral and Duodenal Contraction Amplitude

Summarized as amplitude (strength of contractions)

Time frame
During gastrointestinal motility study (approx. 8 hours)
3

Gastrointestinal Antral and Duodenal Phasic Pressure Activity - Motility Index

Composite measure combining frequency and amplitude for overall assessment of motility

Time frame
During gastrointestinal motility study (approx. 8 hours)
4

Principal Gastric Frequency

Dominant frequency of gastric waves (cycles per minute)

Time frame
During gastrointestinal motility study (8 hours)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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