Gastroparesis Registry 4 Studying Symptoms and Differences in Gastroparesis and Functional Dyspepsia in Adults
Led by Johns Hopkins Bloomberg School of Public Health · Updated on 2026-04-03
250
Participants Needed
6
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying patients with symptoms of gastroparesis and functional dyspepsia, conditions that affect stomach emptying and cause digestive discomfort. This observational study aims to understand the clinical, physiological, and psychological differences and similarities between patients with delayed or normal gastric emptying. The study will focus on symptom severity changes over 48 weeks using a specific patient questionnaire.
Participants will be grouped based on their gastroparesis symptoms with or without delayed gastric emptying. The study involves completing questionnaires, a nutrient drink test, and undergoing a gastric emptying study to assess stomach function. These evaluations will be done at the beginning and followed up to 48 weeks to monitor symptom and physiological changes.
During the study, participants will provide demographic, clinical, and patient outcome data. They will complete several questionnaires and tests, including gastric emptying scintigraphy and symptom assessments at baseline and after 48 weeks. Researchers will monitor symptom severity changes and gastric emptying measures to better characterize the clinical course of these digestive disorders over time.
CONDITIONS
Brief Title
Gastroparesis Registry 4
Research Team
L
Laura Miriel
E
Emily Mitchell, MS, MBA
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Texas Tech University Health Sciences Center, El Paso
Collaborating Sponsor
Who Can Participate
Age: 18Years - 85Years
All Genders
Eligibility Criteria
You may qualify if you...
Age at least 18 years at initial screening visit
Symptoms of gastroparesis and/or functional dyspepsia lasting at least 12 weeks with nausea, vomiting, early satiety, postprandial fullness, abdominal pain, or burning
Completed gastric emptying scintigraphy of solids using the 4-hour Egg Beaters® protocol or equivalent within the last 9 months
Negative upper endoscopy or upper radiographic GI series within 5 years of registration
You will not qualify if you...
Use of narcotic analgesics more than three days per week
Presence of other conditions explaining symptoms such as pyloric or intestinal obstruction, active inflammatory bowel disease, eosinophilic gastroenteritis or esophagitis
Primary neurological conditions causing nausea or vomiting
Acute or chronic renal failure with high creatinine or dialysis
Acute liver failure or advanced liver disease (Child's B or C, CPT score ≥7)
Pancreatic disorders detected by imaging or function tests
Prior gastric surgery including total or subtotal gastric resection, esophagectomy, gastrojejunostomy, gastric bypass, gastric sleeve, pyloroplasty, pyloromyotomy, or fundoplication
Other conditions interfering with symptoms or study requirements
Pregnant females
Inability to complete gastric emptying scintigraphy test or allergy to eggs
Inability to provide informed consent
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Baseline
Participants undergo gastric emptying scintigraphy and other assessments to evaluate gastroparesis and functional dyspepsia symptoms.
1 visit (in-person)
Long-term Monitoring
Duration - 48 weeks
Participants are monitored to assess changes in symptom severity and gastric emptying over 48 weeks.
Assessments at baseline and at 48 weeks
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Effectiveness of gastric electrical stimulation in gastroparesis: Results from a large prospectively collected database of national gastroparesis registries.
Thomas L Abell, Goro Yamada, Richard W McCallum...
Consensus recommendations for gastric emptying scintigraphy: a joint report of the American Neurogastroenterology and Motility Society and the Society of Nuclear Medicine.
Thomas L Abell, Michael Camilleri, Kevin Donohoe...