Gastroparesis Registry 4

{ "Gastroparesis Registry 4", "This is an observational study called Gastroparesis Registry 4 (GpR4) for people with symptoms of gastroparesis (Gp) and/or functional dyspepsia (FD). Gastroparesis is a condition where your stomach empties food too slowly, and functional dyspepsia causes ongoing indigestion symptoms. This study aims to better understand these conditions by collecting information about your health, symptoms, and how your condition changes over time. You would complete questionnaires, have a nutrient drink test, and a gastric emptying study. The main goal is to measure changes in your symptom severity using a special questionnaire over 48 weeks. This study is open to adults aged 18 to 85 who have had symptoms for at least 12 weeks.", "design": "This is an observational study, meaning researchers will collect information about your condition without giving you a specific treatment. It plans to include about 250 participants.", "commitments": "You would complete several questionnaires, a nutrient drink test, and a gastric emptying study. Your symptom severity will be measured over 48 weeks.", "compensation": "Not stated in the trial record.", "follow_up": "Your symptom severity will be measured at 48 weeks.", }

Study design: Not specified.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Gastroparesis Registry 4

Recruiting

Not specifiedAges 18–85Observational

Johns Hopkins Bloomberg School of Public Health

~250 participants

Updated 2026-04-03 on ClinicalTrials.gov

At a glance

Recruiting sites

6 of 6 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Measure of symptom severity of gastroparesis and functional dyspepsia using the change in total score from the Patient Assessment of Upper Gastrointestinal Disorders Symptoms (PAGI SYM) from baseline to 48 weeks.

Measured over 48 weeks

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

Where it's being run

6 sites across 6 states

Arizona1

Kentucky1

Massachusetts1

North Carolina1

Pennsylvania1

Texas1

Study leadership

Jay Pasricha, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Henry Parkman, MD · PRINCIPAL_INVESTIGATOR · Temple University
David Shade, JD · PRINCIPAL_INVESTIGATOR · Johns Hopkins Bloomberg School of Public Health

Who to contact

Laura Miriel

[email protected]

4435024165

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

Measure of symptom severity of gastroparesis and functional dyspepsia using the change in total score from the Patient Assessment of Upper Gastrointestinal Disorders Symptoms (PAGI SYM) from baseline to 48 weeks.48 weeks
Change in PAGI-SYM total score from baseline to 48 weeks. The final PAGI-SYM contains 20 items grouped into 6 subscales covering: heartburn/regurgitation (7 items), nausea/vomiting (3 items), post-prandial fullness/early satiety (4 items), bloating (2 items), upper abdominal pain (2 items), and lower abdominal pain (2 items). A 6-point Likert response scale, ranging from 0 (none) to 5 (very severe), is used for rating the severity of each symptom item over a 2-week recall period. * Subscale scores vary from 0 to 5 * Total score varies from 0 to 5 * Lower score = better health

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