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Gastroparesis Registry 4

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will complete several questionnaires, complete a nutrient drink test and have a gastric emptying study."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study follows adults with symptoms of gastroparesis (slow stomach emptying) or functional dyspepsia (ongoing upper belly discomfort). It aims to learn more about these conditions in people whose stomachs empty slowly or normally. Participants answer surveys, take a nutrient drink test, and have a test of how their stomach empties.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old at the first screening visit.
  • Have symptoms for at least 12 weeks, such as nausea, vomiting, feeling full too soon or after meals, or belly pain or burning.
  • Have completed a 4-hour stomach-emptying scan using Egg Beaters or a similar egg white meal within the past 9 months.
  • Have had an upper digestive tract camera exam or X-ray test within the past 5 years that found no cause for the symptoms.

Who can't join

  • Use opioid pain medicines more than 3 days a week.
  • Have a blocked stomach outlet or intestine, active inflammatory bowel disease, or known inflammation caused by eosinophils (a type of white blood cell) in the food pipe, stomach, or intestines.
  • Have a brain or nerve condition that can cause nausea and vomiting.
  • Have kidney failure with a creatinine blood level above 3 mg/dL, receive dialysis (blood-filtering treatment), have sudden liver failure or advanced liver disease, or have a pancreas disorder found on testing.
  • Have had certain stomach or food pipe surgeries, including removal of all or most of the stomach, food pipe removal, stomach bypass or sleeve surgery, surgery on the stomach outlet, or surgery that wraps the top of the stomach around the food pipe.
  • Have another condition that the study doctor thinks could explain the symptoms or prevent you from meeting study requirements.
  • Be pregnant. A urine pregnancy test is routinely done before stomach-emptying tests.
  • Be unable to complete the stomach-emptying scan, including because of an egg allergy, or be unable to give informed consent (agreement after learning about the study).

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (6)

AZ

KY

MA

NC

PA

TX