Electrogastrogram (EGG) Reproducibility Study: EEG Readings in Normal Subjects and Dyspeptic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00220883
Recruitment Status : Unknown
Verified September 2005 by Temple University.
Recruitment status was:  Recruiting
First Posted : September 22, 2005
Last Update Posted : February 7, 2006
Information provided by:
Temple University

Brief Summary:

The primary objective of this study is to determine whether EGG readings obtained from both normal subjects and dyspeptic patients are reproducible from one EGG recording to another on a different day.

The secondary objective of this study is to determine whether the EGG readings are analyzed and diagnosed consistently when reviewed and compared by multiple blinded readers when the same tracing is reviewed.

Condition or disease
Functional Dyspepsia

Detailed Description:

This is a single-center study. The duration of this trial is estimated to be six months. A total of Forty (40) subjects will be recruited into this study. It will be two Groups; ten (10) normal healthy subjects will be recruited by poster advertisement and thirty (30) patients who either present to the Gastroenterology Department of Temple University Hospital with varying signs, symptoms or complaints of gastric discomfort, or who are scheduled to undergo an EGG test by their Gastroenterologist.

Each study subject/patient will have a total of two (2) EGGs with Water load tests performed for this study. Each EGG exam will be performed approximately one (1) week of each other, but no more than 4 weeks apart, and will be read in a blinded fashion by three (3) separate independent readers, in order to see if the readings are consistent with the previous readings that were obtained, as well as, by the readers themselves (Inter-reader rater reliability). Each reader will be blinded to the subject status (normal/healthy or patient) and also to the specific test they are reading (initial exam [Visit 1], or follow-up exam 1 week after Visit 1 [Visit 2]). All EGG exam results will be coded in order to keep them blind.

Study Type : Observational
Enrollment : 40 participants
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: Reproducibility and Inter-Reader Reliability of Electrogastrographic Readings in Normal Subjects and Dyspeptic Patients
Study Start Date : August 2005
Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 72 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

For normal healthy subjects:

Inclusion Criteria:

  1. Male or female patients who are 18 years of age to 72 years of age.
  2. Normal healthy subjects with no signs or symptoms of gastrointestinal discomfort.

Exclusion Criteria:

Patients will not be included in this study if they are:

  1. < 18 years of age or >72 years of age
  2. Subjects with known gastrointestinal or liver cancers, pancreaticobiliary tract diseases, active peptic ulcer disease or uncontrolled lactose intolerance.
  3. Subjects with cardiovascular, pulmonary disorders, or subjects with diabetes mellitus, a malignancy or who are known to be HIV positive.
  4. Subjects with a history of gastric, intestinal or colonic resections. Subjects who are at less than a three month status for either: post appendectomy, cholecystectomy, or hysterectomy with or without oophorectomy.
  5. Subjects who are unable to give informed consent or adequately express their subjective complaints.
  6. Subjects who abuse drugs or alcohol.
  7. Female subjects who are pregnant.

For functional dyspepsia patients:

Inclusion Criteria:

  1. Male or female patients who are 18 to 72 years of age.
  2. Patients who present with varying gastric complaints of discomfort
  3. Patients who meet all Rome II criteria for functional dyspepsia (see Rome II criteria checklist)

Concomitant medications are allowed during the study period.

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 identifier (NCT number): NCT00220883

Contact: Henry P Parkman, MD 1-215-707-7579

United States, Pennsylvania
Temple University School of Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Henry P. Parkman, MD    215-707-3431   
Principal Investigator: Henry P. Parkman, MD         
Sponsors and Collaborators
Temple University
Principal Investigator: Henry P Parkman, MD Temple University Identifier: NCT00220883     History of Changes
Other Study ID Numbers: TU4687
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: February 7, 2006
Last Verified: September 2005

Keywords provided by Temple University:
Functional Dyspepsia

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