Use of MRI for Assessing Stomach Relaxation in Response to a Meal

Mayo Clinic

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Dyspepsia

Treatments

Procedure: MRI

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00275743

05-004022

Details and patient eligibility

About

This study is being done to test new way of measuring the relaxation of the stomach after a meal (called gastric accommodation) by using a MRI scan. This new test will be compared with the standard test of measuring stomach relaxation that uses radioactive tracers. These tests will be compared in healthy volunteers and people with upper abdominal symptoms (known as dyspepsia).

Enrollment

50 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria for Dyspeptic patients (30 required)

One or more of eight postprandial dyspeptic symptoms i.e. fullness, bloating, epigastric discomfort, early satiety, nausea, vomiting, belching, pain for a minimum of 3 months, OR
Patients fulfilling the ROME-II criteria for functional dyspepsia,
AND no symptom improvement after standard dose PPI treatment,
AND normal upper gastrointestinal endoscopy within six months prior to the study

Inclusion Criteria for Healthy Controls (20 required)

• Absence of current abdominal symptoms or depression

Exclusion Criteria for all Participants

Known structural upper GI disorder (e.g. peptic ulcer disease, esophagitis, malignancy);
Abdominal surgery other than appendectomy, cholecystectomy, hysterectomy, tubal ligation, or inguinal hernia repair;
Medications that may alter gastrointestinal motility, e.g., serotoninergic agents, alpha adrenergic agonists, calcium channel or beta blockers; stable dose of thyroxine will be permitted;
Pregnant or breast-feeding females;
Known claustrophobia;
Any metal objects in the body (e.g. metal implants, pacemaker, AICD)