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

This study has been completed.
Sponsor:
Collaborators:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00275743
First received: January 10, 2006
Last updated: April 27, 2009
Last verified: April 2009
  Purpose

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 Intervention Phase
Dyspepsia
Healthy Volunteers
Procedure: MRI
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Dynamic MRI - A Novel Approach for Measuring Gastric Accommodation

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Gastric Volume (fasting and postprandial)
  • Antral Contractility

Estimated Enrollment: 50
Study Start Date: October 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00275743

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Adil E. Bharucha, M.B.B.S., M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Adil Bharucha, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00275743     History of Changes
Other Study ID Numbers: 05-004022
Study First Received: January 10, 2006
Last Updated: April 27, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014