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

NCT ID: NCT00220883

Last Updated: 2020-08-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2006-09-30

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.

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.

Conditions

Functional Dyspepsia

Study Design

• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

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.

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:

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 72 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Temple University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Henry P Parkman, MD

Role: PRINCIPAL_INVESTIGATOR

Temple University

Locations

Temple University School of Medicine

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

TU4687

Identifier Type: -

Identifier Source: org_study_id