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

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ClinicalTrials.gov Identifier: NCT00275743
Recruitment Status : Completed
First Posted : January 12, 2006
Last Update Posted : April 29, 2009
Sponsor:
Collaborators:
Information provided by:

Study Description
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 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).

Condition or disease Intervention/treatment Phase
Dyspepsia Healthy Volunteers Procedure: MRI Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Dynamic MRI - A Novel Approach for Measuring Gastric Accommodation
Study Start Date : October 2005
Primary Completion Date : December 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Gastric Volume (fasting and postprandial)
  2. Antral Contractility

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00275743


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Adil E. Bharucha, M.B.B.S., M.D. Mayo Clinic
More Information

Responsible Party: Adil Bharucha, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00275743     History of Changes
Other Study ID Numbers: 05-004022
First Posted: January 12, 2006    Key Record Dates
Last Update Posted: April 29, 2009
Last Verified: April 2009

Additional relevant MeSH terms:
Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms