250 Participants Needed

Registry for Gastroparesis

(GpR4 Trial)

Recruiting at 6 trial locations
LM
EM
Overseen ByEmily Mitchell, MS, MBA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Johns Hopkins Bloomberg School of Public Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is an observational study focusing on individuals with symptoms of gastroparesis or functional dyspepsia, conditions that affect how the stomach empties food. The researchers aim to gather information on these conditions by collecting data from participants, such as their symptoms and test results. Participants will complete questionnaires and undergo tests like a nutrient drink test and a gastric emptying study. This trial suits those who have experienced symptoms like nausea, vomiting, or stomach pain for at least 12 weeks and can complete specific medical tests. As an unphased trial, it offers participants the opportunity to contribute valuable data that could lead to better understanding and management of their condition.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you use narcotic painkillers more than three days a week.

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to gather comprehensive data on gastroparesis, a condition where the stomach cannot empty properly. Unlike treatments that focus solely on symptom relief, this observational study seeks to understand the condition more deeply by tracking a wide range of patient experiences and health outcomes. This could lead to identifying new patterns or causes of gastroparesis, ultimately paving the way for more targeted and effective treatments in the future. By compiling extensive real-world data, researchers hope to uncover insights that could revolutionize how we approach and manage this challenging digestive disorder.

Who Is on the Research Team?

JP

Jay Pasricha, MD

Principal Investigator

Mayo Clinic

HP

Henry Parkman, MD

Principal Investigator

Temple University

DS

David Shade, JD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Are You a Good Fit for This Trial?

Inclusion Criteria

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 6 months
Negative upper endoscopy or upper radiographic GI series within 2 years of registration

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Baseline Assessment

Participants undergo baseline assessments including gastric emptying scintigraphy and evaluation of Carnett's sign

1-2 weeks
1 visit (in-person)

Observational Period

Participants are observed for changes in symptom severity and gastric emptying over time

48 weeks
Regular assessments (in-person and virtual)

Follow-up

Participants are monitored for safety and effectiveness after the observational period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Observational Study

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins Bloomberg School of Public Health

Lead Sponsor

Trials
441
Recruited
2,157,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Wake Forest University

Collaborator

Trials
193
Recruited
151,000+

Massachusetts General Hospital

Collaborator

Trials
3,066
Recruited
13,430,000+

Texas Tech University Health Sciences Center, El Paso

Collaborator

Trials
51
Recruited
5,800+

Temple University

Collaborator

Trials
321
Recruited
89,100+

University of Louisville

Collaborator

Trials
353
Recruited
76,400+

Mayo Clinic

Collaborator

Trials
3,427
Recruited
3,221,000+