RECRUITING

Gastroparesis Registry 4

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Conditions

GastroparesisGastroparesis NondiabeticGastroparesis Due to Diabetes Mellitus Type IGastroparesis Due to Diabetes Mellitus Type IIFunctional Disorder of Gastrointestinal TractGastro-Intestinal Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-09-20
Study Completion:2027-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05846802

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age at least 18 years at initial screening visit
  2. * 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.
  3. * 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
  4. * Negative upper endoscopy or upper radiographic GI series within 2 years of registration
  1. * Use of narcotic analgesics greater than three days per week
  2. * Presence of other conditions that could explain the patient's symptoms such as:
  3. * Pyloric or intestinal obstruction as evidenced by EGD, UGI, or Abdominal CT
  4. * Active inflammatory bowel disease
  5. * Known eosinophilic gastroenteritis or eosinophilic esophagitis
  6. * Primary neurological conditions that can cause nausea and vomiting such as increased intracranial pressure, space occupying or inflammatory/infectious lesions
  7. * Acute or chronic renal failure (serum creatinine \>3 mg/dL) and/or on hemodialysis or peritoneal dialysis
  8. * Acute liver failure or advanced liver disease (Child's B or C; a Child-Pugh-Turcotte (CPT) score of ≥7)
  9. * Pancreatic disorder if present on pancreatic imaging or pancreatic function testing
  10. * Prior gastric surgery including total or subtotal (near complete) gastric resection, esophagectomy, gastrojejunostomy, gastric bypass, gastric sleeve, pyloroplasty, pyloromyotomy, or any fundoplication (Nissen, Tor)
  11. * Any other condition, which in the opinion of the investigator, could explain the symptoms or interfere with study requirements
  12. * Females who are pregnant. A urine pregnancy test is routinely obtained on all females immediately prior to gastric emptying procedures.
  13. * Inability to comply with or complete the gastric emptying scintigraphy test (including allergy to eggs)
  14. * Inability to obtain informed consent

Contacts and Locations

Study Contact

Laura Miriel
CONTACT
4435024165
lmiriel1@jhu.edu
Emily Mitchell, MS, MBA
CONTACT
esharke5@jhu.edu

Principal Investigator

Jay Pasricha, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic
Henry Parkman, MD
PRINCIPAL_INVESTIGATOR
Temple University
David Shade, JD
PRINCIPAL_INVESTIGATOR
Johns Hopkins Bloomberg School of Public Health

Study Locations (Sites)

Jay Pasricha
Scottsdale, Arizona, 85259
United States
University of Louisville
Louisville, Kentucky, 40202
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Wake Forest University and Atrium Health Carolinas Medical Center
Charlotte, North Carolina, 28202
United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140
United States
Texas Tech University Health Science Center (TTUHSC)
El Paso, Texas, 79905
United States

Collaborators and Investigators

Sponsor: Johns Hopkins Bloomberg School of Public Health

  • Jay Pasricha, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic
  • Henry Parkman, MD, PRINCIPAL_INVESTIGATOR, Temple University
  • David Shade, JD, PRINCIPAL_INVESTIGATOR, Johns Hopkins Bloomberg School of Public Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-20
Study Completion Date2027-04-30

Study Record Updates

Study Start Date2024-09-20
Study Completion Date2027-04-30

Terms related to this study

Additional Relevant MeSH Terms

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