Status:
COMPLETED
Electrogastrogram (EGG) Reproducibility Study: EEG Readings in Normal Subjects and Dyspeptic Patients
Lead Sponsor:
Temple University
Conditions:
Functional Dyspepsia
Eligibility:
All Genders
18-72 years
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...
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 health...
Eligibility Criteria
Inclusion
- For normal healthy subjects:
- Male or female patients who are 18 years of age to 72 years of age.
- Normal healthy subjects with no signs or symptoms of gastrointestinal discomfort.
Exclusion
- Patients will not be included in this study if they are:
- \< 18 years of age or \>72 years of age
- Subjects with known gastrointestinal or liver cancers, pancreaticobiliary tract diseases, active peptic ulcer disease or uncontrolled lactose intolerance.
- Subjects with cardiovascular, pulmonary disorders, or subjects with diabetes mellitus, a malignancy or who are known to be HIV positive.
- 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.
- Subjects who are unable to give informed consent or adequately express their subjective complaints.
- Subjects who abuse drugs or alcohol.
- Female subjects who are pregnant.
- For functional dyspepsia patients:
- Inclusion Criteria:
- Male or female patients who are 18 to 72 years of age.
- Patients who present with varying gastric complaints of discomfort
- Patients who meet all Rome II criteria for functional dyspepsia (see Rome II criteria checklist)
- Concomitant medications are allowed during the study period.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00220883
Start Date
August 1 2005
End Date
September 1 2006
Last Update
August 17 2020
Active Locations (1)
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1
Temple University School of Medicine
Philadelphia, Pennsylvania, United States, 19140