American Gastroenterological Association technical review on the diagnosis and treatment of gastroparesis.
Henry P Parkman, William L Hasler, Robert S Fisher...
https://pubmed.ncbi.nlm.nih.gov/15521026Actively Recruiting
Age: 18Years - 85Years
All Genders
ID05846802
Gastroparesis Registry 4 (GpR4): Improving the Understanding of Gastroparesis and Functional Dyspepsia
Led by Johns Hopkins Bloomberg School of Public Health · Updated on 2026-04-03
250
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
Sponsors
J
Johns Hopkins Bloomberg School of Public Health
Lead Sponsor
T
Texas Tech University Health Sciences Center, El Paso
Collaborating Sponsor
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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
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
Trial Site Locations
Total: 6 locations
1
Jay Pasricha
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
4
Wake Forest University and Atrium Health Carolinas Medical Center
Charlotte, North Carolina, United States, 28202
Actively Recruiting
5
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
6
Texas Tech University Health Science Center (TTUHSC)
El Paso, Texas, United States, 79905
Actively Recruiting
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Research Team
L
Laura Miriel
E
Emily Mitchell, MS, MBA
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
Clinical guideline: management of gastroparesis.
Michael Camilleri, Henry P Parkman, Mehnaz A Shafi...
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Vincenzo Stanghellini, Francis K L Chan, William L Hasler...
https://pubmed.ncbi.nlm.nih.gov/27147122United European Gastroenterology (UEG) and European Society for Neurogastroenterology and Motility (ESNM) consensus on gastroparesis.
Jolien Schol, Lucas Wauters, Ram Dickman...
https://pubmed.ncbi.nlm.nih.gov/34399024Functional Dyspepsia and Gastroparesis in Tertiary Care are Interchangeable Syndromes With Common Clinical and Pathologic Features.
Pankaj J Pasricha, Madhusudan Grover, Katherine P Yates...
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Brian E Lacy, Michael D Crowell, David J Cangemi...
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D A Revicki, M Camilleri, B Kuo...
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