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

NCT ID: NCT00275743

Last Updated: 2009-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2008-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Dyspepsia Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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MRI

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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


• Absence of current abdominal symptoms or depression

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

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

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mayo Clinic

Principal Investigators

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Adil E. Bharucha, M.B.B.S., M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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05-004022

Identifier Type: -

Identifier Source: org_study_id