Recruiting

Observational Study

Sponsor:

Johns Hopkins Bloomberg School of Public Health

Code:

NCT05846802

Conditions

Gastroparesis

Gastroparesis Nondiabetic

Gastroparesis Due to Diabetes Mellitus Type I

Gastroparesis Due to Diabetes Mellitus Type II

Functional Disorder of Gastrointestinal Tract

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Gastroparesis

Gastroparesis Nondiabetic

Gastroparesis Due to Diabetes Mellitus Type I

Gastroparesis Due to Diabetes Mellitus Type II

Functional Disorder of Gastrointestinal Tract

Study ID

NCT05846802

Start date

Sep 20, 2024

Status verified date

Mar, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Arms

Gastroparesis

Gastroparesis symptoms with delayed emptying

Functional Dyspepsia

Gastroparesis symptoms without delayed emptying

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Laura Miriel

4435024165lmiriel1@jhu.edu

Emily Mitchell, MS, MBA

esharke5@jhu.edu

Locations

Jay Pasricha

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Jay Pasricha, MD

pasricha.jay@mayo.org

Guillermo Barahona

Barahona.Guillermo@mayo.edu

Principal Investigator:

Jay Pasricha, MD

University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Thomas Abell, MD

502-852-7963thomas.abell@louisville.edu

Bridget Cannon

(502) 540-1428Bridget.cannon@louisville.edu

Principal Investigator:

Thomas L Abell, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Helen B Murray, PhD

617-726-8470hbmurray@mgh.harvard.edu

Madison Paylor

(410)916-9307mpaylor@mgh.harvard.edu

Principal Investigator:

Braden Kuo, MD

Wake Forest University and Atrium Health Carolinas Medical Center

Recruiting

Charlotte, North Carolina, United States, 28202

Contacts

Baha Moshiree, MD

704-355-4593

Kelsey Cuzzupe

704-355-4593Kelsey.Cuzzupe@advocatehealth.org

Principal Investigator:

Baha Moshiree, MD

Temple University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contacts

Henry Parkman, MD

215-707-7579henry.parkman@temple.edu

Rona T Cooper

2157075477rona.taylor@temple.edu

Principal Investigator:

Henry Parkman, MD

Texas Tech University Health Science Center (TTUHSC)

Recruiting

El Paso, Texas, United States, 79905

Contacts

Irene Sarosiek, MD

915-545-6626irene.sarosiek@ttuhsc.edu

Denise Vasquez

(915) 214-4388denise.vasquez@ttuhsc.edu

Principal Investigator:

Irene Sarosiek

More Information

Sponsor

Johns Hopkins Bloomberg School of Public Health

Last update posted

Apr 3, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Johns Hopkins Bloomberg School of Public Health on 2026-04-03. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.