Gastroparesis Registry 4

Last updated: April 16, 2025
Sponsor: Johns Hopkins Bloomberg School of Public Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ulcers

Diabetes Prevention

Gastrointestinal Diseases And Disorders

Treatment

N/A

Clinical Study ID

NCT05846802
14-DK-GpR4
U01DK112193
IRB00401119
U01DK073975
U24DK074008
U01DK074035
U01DK073983
U01DK074007
U01DK073974
  • Ages 18-85
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 ofnausea, vomiting, early satiety, postprandial fullness, abdominal pain, abdominalburning. Thus, patients can enter the GpR4 registry primarily with abdominal painsuggesting FD-Epigastric Pain Syndrome.

  • Successful completion of gastric emptying scintigraphy of solids using the 4-hourEgg 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 ofregistration

Exclusion

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 increasedintracranial pressure, space occupying or inflammatory/infectious lesions

  • Acute or chronic renal failure (serum creatinine >3 mg/dL) and/or on hemodialysis orperitoneal 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 thesymptoms or interfere with study requirements

  • Females who are pregnant. A urine pregnancy test is routinely obtained on allfemales 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 Design

Total Participants: 250
Study Start date:
September 20, 2024
Estimated Completion Date:
April 30, 2027

Study 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.

Connect with a study center

  • Jay Pasricha

    Scottsdale, Arizona 85259
    United States

    Active - Recruiting

  • University of Louisville

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Wake Forest University and Atrium Health Carolinas Medical Center

    Charlotte, North Carolina 28202
    United States

    Active - Recruiting

  • Kenneth Koch

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Temple University Hospital

    Philadelphia, Pennsylvania 19140
    United States

    Active - Recruiting

  • Texas Tech University Health Science Center (TTUHSC)

    El Paso, Texas 79905
    United States

    Active - Recruiting

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