Taking people in United StatesNo phase

Studying Gastroparesis and Functional Dyspepsia Over Time in Adults

Records symptoms, stomach emptying and questionnaires in adults with gastroparesis or dyspepsia.

Key facts

Who runs it: Johns Hopkins Bloomberg School of Public Health
Where: Boston, Charlotte, El Paso, Louisville, Philadelphia, and Scottsdale, United StatesSee the 6 sites
Trial code: NCT05846802
Registry title: Gastroparesis Registry 4
Status: Recruiting
People taking part: 250 people, planned
Started: 20 Sept 2024
Expected to end: 30 Apr 2027
Type of study: Observational, 2 groups
Record updated: 3 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with symptoms of gastroparesis or functional dyspepsia, with delayed or normal stomach emptying.

Age: 18 to 85 years
Sex: All sexes can join.
Disease stage: Symptoms of gastroparesis and/or functional dyspepsia for at least 12 weeks, such as nausea, vomiting, early fullness, bloating after meals, or stomach pain or burning.
Earlier treatment: A stomach emptying scan (4-hour egg meal protocol) completed within the last 9 months. No past stomach surgery such as gastric bypass, gastric sleeve or fundoplication.
Biomarker or test result: A negative upper endoscopy or upper X-ray series within 5 years of joining.

Main reasons for not taking part

Use of narcotic pain medicine more than three days per week
Another condition that could explain the symptoms, such as a blocked stomach outlet or bowel, or active inflammatory bowel disease
Kidney failure or dialysis, or serious liver disease
Pregnancy
Cannot complete the stomach emptying test, including egg allergy

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

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

Who cannot take part

Prior gastric surgery including total or subtotal (near complete) gastric resection, esophagectomy, gastrojejunostomy, gastric bypass, gastric sleeve, pyloroplasty, pyloromyotomy, or any fundoplication (Nissen, Tor)
Females who are pregnant. A urine pregnancy test is routinely obtained on all females immediately prior to gastric emptying procedures
Presence of other conditions that could explain the patient's symptoms such as:
Active inflammatory bowel disease
Primary neurological conditions that can cause nausea and vomiting such as increased intracranial pressure, space occupying or inflammatory/infectious lesions
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
Any other condition, which in the opinion of the investigator, could explain the symptoms or interfere with study requirements
Inability to comply with or complete the gastric emptying scintigraphy test (including allergy to eggs)
Acute or chronic renal failure (serum creatinine >3 mg/dL) and/or on hemodialysis or peritoneal dialysis
Use of narcotic analgesics greater than three days per week
Pyloric or intestinal obstruction as evidenced by EGD, UGI, or Abdominal CT
Known eosinophilic gastroenteritis or eosinophilic esophagitis
Inability to obtain informed consent

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 85 years old?

Where in United States

Massachusetts General HospitalBoston, United StatesContact: Helen B Murray, PhDTaking people
Wake Forest University and Atrium Health Carolinas Medical CenterCharlotte, United StatesContact: Baha Moshiree, MDTaking people
Texas Tech University Health Science Center (TTUHSC)El Paso, United StatesContact: Irene Sarosiek, MDTaking people
University of LouisvilleLouisville, United StatesContact: Thomas Abell, MDTaking people
Temple University HospitalPhiladelphia, United StatesContact: Henry Parkman, MDTaking people
Jay PasrichaScottsdale, United StatesContact: Jay Pasricha, MDTaking people

About the trial

What the trial wants to find out

The Gastroparesis Registry 4 (GpR4) is an observational study of patients with symptoms of gastroparesis (Gp) and functional dyspepsia (FD) with either delayed or normal gastric emptying. To better understand these disorders, this registry will capture demographic, clinical, physiological, questionnaire, and patient outcome data to characterize the patients and their clinical course. Participants will complete several questionnaires, complete a nutrient drink test and have a gastric emptying study.