Dyspepsia
Conditions
Brief summary
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.
Interventions
BEHAVIORALGastric Motor Function Measurement
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting and postprandial gastric volumes (Gastric accommodation) | — |
Secondary
| Measure | Time frame |
|---|---|
| T1/2 of gastric emptying of solid | — |
| Maximum tolerated volume | — |
| Individual postprandial symptom scores | — |
Countries
United States
Outcome results
None listed