Status:
COMPLETED
Use of MRI for Assessing Stomach Relaxation in Response to a Meal
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Dyspepsia
Healthy Volunteers
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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 te...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00275743
Start Date
October 1 2005
End Date
December 1 2008
Last Update
April 29 2009
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905