Gastroparesis Registry 4 (GpR4)

March 30, 2026 updated by: Johns Hopkins Bloomberg School of Public Health

Gastroparesis Registry 4 (GpR4): Improving the Understanding of Gastroparesis and Functional Dyspepsia

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This observational study of patients with symptoms of gastroparesis (Gp) and functional dyspepsia (FD) with either delayed or normal gastric emptying aims to assess the clinical, pathophysiological, and psychological similarities and differences between patients with Gp, FD.

The primary outcome will be the 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.

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
    • Kentucky
      • Louisville, Kentucky, United States, 40202
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • Braden Kuo, MD
        • Contact:
        • Principal Investigator:
          • Nir Bar, MD
        • Contact:
    • North Carolina
      • Charlotte, North Carolina, United States, 28202
        • Recruiting
        • Wake Forest University and Atrium Health Carolinas Medical Center
        • Principal Investigator:
          • Baha Moshiree, MD
        • Contact:
          • Baha Moshiree, MD
          • Phone Number: 704-355-4593
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Recruiting
        • Temple University Hospital
        • Contact:
        • Principal Investigator:
          • Henry Parkman, MD
        • Contact:
    • Texas
      • El Paso, Texas, United States, 79905
        • Recruiting
        • Texas Tech University Health Science Center (TTUHSC)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Irene Sarosiek

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults over age 18, located in the United States, with symptoms of gastroparesis and/or functional dyspepsia.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Gastroparesis
Gastroparesis symptoms with delayed emptying
Functional Dyspepsia
Gastroparesis symptoms without delayed emptying

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in gastric emptying, as measured by gastric emptying scintigraphy (GES) at baseline and 48 weeks
Time Frame: Baseline, 48 weeks

Changes in gastric emptying, as measured by gastric emptying scintigraphy (GES) at baseline and 48 weeks.

Normal values for gastric emptying scintigraphy have been established in earlier studies using healthy volunteers. Gastric retention of 99mTc > 60% at 2 hours and/or > 10% at 4 hours is considered evidence of delayed gastric emptying of solids.
Baseline, 48 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence or absence of Carnett's sign for abdominal wall pain at baseline.
Time Frame: Baseline

Presence or absence Carnett's sign for abdominal wall pain at baseline. Carnett's sign is a finding on clinical examination in which (acute) abdominal pain remains unchanged or increases when the muscles of the abdominal wall are tensed. As part of the abdominal examination, the patient is asked to lift the head and shoulders from the examination table to tense the abdominal muscles. An alternative is to ask the patient to raise both legs with straight knees.

A positive test indicates the increased likelihood that the abdominal wall and not the abdominal cavity is the source of the pain (for example, due to rectus sheath hematoma instead of appendicitis). A negative Carnett's sign is said to occur when the abdominal pain decreases when the patient is asked to lift the head; this points to an intra-abdominal cause of the pain
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

Massachusetts General Hospital
Mayo Clinic
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Temple University
University of Louisville
Texas Tech University Health Sciences Center, El Paso
Wake Forest University

Investigators

  • Principal Investigator: Jay Pasricha, MD, Mayo Clinic
  • Principal Investigator: Henry Parkman, MD, Temple University
  • Principal Investigator: David Shade, JD, Johns Hopkins Bloomberg School of Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2024

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

April 25, 2023

First Submitted That Met QC Criteria

May 4, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-DK-GpR4
  • U24DK074008 (U.S. NIH Grant/Contract)
  • U01DK073983 (U.S. NIH Grant/Contract)
  • U01DK112193 (U.S. NIH Grant/Contract)
  • U01DK073975 (U.S. NIH Grant/Contract)
  • U01DK074035 (U.S. NIH Grant/Contract)
  • U01DK074007 (U.S. NIH Grant/Contract)
  • U01DK073974 (U.S. NIH Grant/Contract)
  • IRB00401119 (Other Identifier: JHM IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Public use complete database will be submitted to the NIDDK Data Repository

IPD Sharing Time Frame

Two years after the end of the funding period ends (2029)

IPD Sharing Access Criteria

An investigator interested in acquiring GpR4 study data or biospecimens should contact the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Central Repository

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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