Gastroparesis Registry 4

NCT05846802 | Recruiting DMC

• 9 other identifiers: 14-DK-GpR4U01DK073975U01DK074035U01DK074007U24DK074008U01DK073983U01DK112193U01DK073974IRB00401119
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 6

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 II; Functional Disorder of Gastrointestinal Tract; Gastro-Intestinal Disorder; Gastroparesis Due to Diabetes Mellitus Type I

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (1)

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

  Baseline, 48 weeks

Other Outcomes (1)

• Presence or absence of Carnett's sign for abdominal wall pain at baseline.

  Baseline

Study Arms (2)

Gastroparesis

Gastroparesis symptoms with delayed emptying

Functional Dyspepsia

Gastroparesis symptoms without delayed emptying

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Texas Tech University Health Sciences Center, El Paso: collaborator
• Temple University: collaborator
• University of Louisville: collaborator
• Mayo Clinic: collaborator
• Massachusetts General Hospital: collaborator
• Wake Forest University: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (6)

Jay Pasricha

Scottsdale, Arizona, 85259, United States

RECRUITING

University of Louisville

Louisville, Kentucky, 40202, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Wake Forest University and Atrium Health Carolinas Medical Center

Charlotte, North Carolina, 28202, United States

RECRUITING

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

Texas Tech University Health Science Center (TTUHSC)

El Paso, Texas, 79905, United States

RECRUITING

Related Publications (54)

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• Parkman HP, Yates K, Hasler WL, Nguyen L, Pasricha PJ, Snape WJ, Farrugia G, Koch KL, Abell TL, McCallum RW, Lee L, Unalp-Arida A, Tonascia J, Hamilton F; National Institute of Diabetes and Digestive and Kidney Diseases Gastroparesis Clinical Research Consortium. Clinical features of idiopathic gastroparesis vary with sex, body mass, symptom onset, delay in gastric emptying, and gastroparesis severity. Gastroenterology. 2011 Jan;140(1):101-15. doi: 10.1053/j.gastro.2010.10.015. Epub 2010 Oct 20.

  PMID: 20965184 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

20 mL of fasting blood collected and will be separated into plasma and serum and divided into 0.5 mL aliquots. Aliquots will be kept in a storage facility at -70 degrees C until they are shipped to the NIDDK Central Repository on dry ice for banking. The banked samples will be used for specific GpR4 research questions, GpCRC ancillary studies,and future health-related research..

MeSH Terms

Conditions

Gastroparesis; Gastrointestinal Diseases; Digestive System Diseases

Condition Hierarchy (Ancestors)

Stomach Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jay Pasricha, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Henry Parkman, MD

  Temple University

  PRINCIPAL INVESTIGATOR

• David Shade, JD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Miriel

CONTACT

4435024165; lmiriel1@jhu.edu

Emily Mitchell, MS, MBA

CONTACT

esharke5@jhu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 6, 2023
• Study Start: September 20, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Two years after the end of the funding period ends (2029)
• 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

Locations

US (6)