Registry for patients with gastroparesis and functional dyspepsia
Gastroparesis Registry 4 (GpR4): Improving the Understanding of Gastroparesis and Functional Dyspepsia
Johns Hopkins Bloomberg School of Public Health · NCT05846802
This study is trying to learn more about people with gastroparesis and functional dyspepsia by collecting information on their symptoms and experiences over 48 weeks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Johns Hopkins Bloomberg School of Public Health (other) |
| Locations | 6 sites (Scottsdale, Arizona and 5 other locations) |
| Trial ID | NCT05846802 on ClinicalTrials.gov |
What this trial studies
The Gastroparesis Registry 4 is an observational study that aims to gather comprehensive data on patients experiencing symptoms of gastroparesis and functional dyspepsia. Participants will undergo a series of assessments, including questionnaires, a nutrient drink test, and a gastric emptying study, to evaluate their symptoms and clinical characteristics. The study will focus on understanding the similarities and differences in clinical, pathophysiological, and psychological aspects of these gastrointestinal disorders over a period of 48 weeks.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with symptoms of gastroparesis or functional dyspepsia lasting at least 12 weeks.
Not a fit: Patients with conditions that could explain their symptoms, such as intestinal obstruction or active inflammatory bowel disease, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of gastroparesis and functional dyspepsia, leading to improved patient management and treatment strategies.
How similar studies have performed: Other studies have shown success in characterizing gastrointestinal disorders, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age at least 18 years at initial screening visit * Symptoms of Gp and/or FD of at least 12-weeks duration with varying degrees of nausea, vomiting, early satiety, postprandial fullness, abdominal pain, abdominal burning. Thus, patients can enter the GpR4 registry primarily with abdominal pain suggesting FD-Epigastric Pain Syndrome. * Successful completion of gastric emptying scintigraphy of solids using the 4-hour Egg Beaters® protocol (or equivalent generic liquid egg white meal) within the last 9 months * Negative upper endoscopy or upper radiographic GI series within 5 years of registration Exclusion Criteria: * Use of narcotic analgesics greater than three days per week * Presence of other conditions that could explain the patient's symptoms such as: * Pyloric or intestinal obstruction as evidenced by EGD, UGI, or Abdominal CT * Active inflammatory bowel disease * Known eosinophilic gastroenteritis or eosinophilic esophagitis * Primary neurological conditions that can cause nausea and vomiting such as increased intracranial pressure, space occupying or inflammatory/infectious lesions * Acute or chronic renal failure (serum creatinine \>3 mg/dL) and/or on hemodialysis or peritoneal dialysis * Acute liver failure or advanced liver disease (Child's B or C; a Child-Pugh-Turcotte (CPT) score of ≥7) * Pancreatic disorder if present on pancreatic imaging or pancreatic function testing * Prior gastric surgery including total or subtotal (near complete) gastric resection, esophagectomy, gastrojejunostomy, gastric bypass, gastric sleeve, pyloroplasty, pyloromyotomy, or any fundoplication (Nissen, Tor) * Any other condition, which in the opinion of the investigator, could explain the symptoms or interfere with study requirements * Females who are pregnant. A urine pregnancy test is routinely obtained on all females immediately prior to gastric emptying procedures. * Inability to comply with or complete the gastric emptying scintigraphy test (including allergy to eggs) * Inability to obtain informed consent
Where this trial is running
Scottsdale, Arizona and 5 other locations
- Jay Pasricha — Scottsdale, Arizona, United States (RECRUITING)
- University of Louisville — Louisville, Kentucky, United States (RECRUITING)
- Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
- Wake Forest University and Atrium Health Carolinas Medical Center — Charlotte, North Carolina, United States (RECRUITING)
- Temple University Hospital — Philadelphia, Pennsylvania, United States (RECRUITING)
- Texas Tech University Health Science Center (TTUHSC) — El Paso, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Jay Pasricha, MD — Mayo Clinic
- Study coordinator: Laura Miriel
- Email: lmiriel1@jhu.edu
- Phone: 4435024165
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gastroparesis, Gastroparesis Nondiabetic, Gastroparesis Due to Diabetes Mellitus Type I, Gastroparesis Due to Diabetes Mellitus Type II, Functional Disorder of Gastrointestinal Tract, Gastro-Intestinal Disorder