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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00275743
• Date of registration: 10/01/2006
• Prospective Registration: No
• Primary sponsor: Mayo Clinic
• Public title: Use of MRI for Assessing Stomach Relaxation in Response to a Meal
• Scientific title: Dynamic MRI - A Novel Approach for Measuring Gastric Accommodation
• Date of first enrolment: October 2005
• Target sample size: 50
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00275743
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Adil E. Bharucha, M.B.B.S., M.D.
• Affiliation: Mayo Clinic

Key inclusion & 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)



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy Volunteers

Dyspepsia

Intervention(s)

Procedure: MRI

Primary Outcome(s)

Antral Contractility

Gastric Volume (fasting and postprandial)

Secondary ID(s)

05-004022

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institutes of Health (NIH)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)