Gastric Motor Function Measurement in Dyspepsia and Normal Subjects

Study Overview
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Brief Summary
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This study is being done to measure the functions of the stomach after eating a meal and to develop a new method that will simultaneously measure both gastric emptying and the relaxation of the stomach after a meal using nuclear medicine testing. This would make the testing more convenient for patients and will also offer better understanding of these two gastric functions.

Official Title
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Simultaneous Gastric Motor Function Measurement in Dyspepsia And Normal Subjects Ingesting a Solid-Liquid Meal

Conditions
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Dyspepsia

Intervention / Treatment
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* Behavioral: Gastric Motor Function Measurement


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Dyspeptic Subjects: Recurrent episodes of upper abdominal pain or discomfort including early satiety, fullness, bloating, or nausea for at least 3 months in the prior year. A baseline impaired satiety test (maximum tolerated volume 25% of normal or 1000cc). No evidence on esophagogastroduodenoscopy of erosions, peptic ulcer, pyloric obstruction, esophagitis or malignancy in the prior 3 years. All Subjects: No history suggestive of small bowel obstruction. Exclusion criteria No structural or metabolic diseases/conditions that affect the gastrointestinal system. Unable to stop medications 48 hours prior to the study that: Alter GI transit including laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, narcotics, anticholinergics, tricyclic antidepressants, SSRI and newer antidepressants. Analgesic drugs including opiates, NSAID, COX 2 inhibitors Systemic antifungal drugs Carbamazepine, glucocorticoids, phenobarbital, phenytoin, rifampin, but also grapefruit juice. Benzodiazepines NOTE: Low stable doses of thyroid replacement, estrogen replacement, low dose aspirin for cardioprotection and birth control pills or depot injections are permissible. Female subjects who are pregnant or breast feeding. Significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric, or other disease that interfere with the objectives of the study. Subjects who have participated in another clinical study within the past 30 days. Previous gastric or intestinal surgery (except appendectomy , cholecystectomy or hysterectomy).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Gastric Motor Function Measurement|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting and postprandial gastric volumes (Gastric accommodation) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T1/2 of gastric emptying of solid |  |  | 
| Maximum tolerated volume |  |  | 
| Individual postprandial symptom scores |  |  |