Menu
Recruiting NCT05846802

Gastroparesis Registry 4

— Observational Gastroparesis Gastroparesis Nondiabetic Gastroparesis Due to Diabetes Mellitus Type I Gastroparesis Due to Diabetes Mellitus Type II

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Gastroparesis, Gastroparesis Nondiabetic, Gastroparesis Due to Diabetes Mellitus Type I, Gastroparesis Due to Diabetes Mellitus Type II. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed 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.

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • Changes in gastric emptying, as measured by gastric emptying scintigraphy (GES) at baseline and 48 weeks [Time frame: Baseline, 48 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 6 centers
  • Jay Pasricha — Scottsdale
  • University of Louisville — Louisville
  • Massachusetts General Hospital — Boston
  • Wake Forest University and Atrium Health Carolinas Medical Center — Charlotte
  • Temple University Hospital — Philadelphia
  • Texas Tech University Health Science Center (TTUHSC) — El Paso

Publications

  • Parkman HP, Hasler WL, Fisher RS; American Gastroenterological Association. American Gastroenterological Association technical review on the diagnosis and treatment of gastroparesis. Gastroenterology. 2004 Nov;127(5):1592-622. doi: 10.1053/j.gastro.2004.09.055. PMID 15521026
  • Camilleri M, Parkman HP, Shafi MA, Abell TL, Gerson L; American College of Gastroenterology. Clinical guideline: management of gastroparesis. Am J Gastroenterol. 2013 Jan;108(1):18-37; quiz 38. doi: 10.1038/ajg.2012.373. Epub 2012 Nov 13. PMID 23147521
  • Stanghellini V, Chan FK, Hasler WL, Malagelada JR, Suzuki H, Tack J, Talley NJ. Gastroduodenal Disorders. Gastroenterology. 2016 May;150(6):1380-92. doi: 10.1053/j.gastro.2016.02.011. PMID 27147122
  • Schol J, Wauters L, Dickman R, Drug V, Mulak A, Serra J, Enck P, Tack J; ESNM Gastroparesis Consensus Group. United European Gastroenterology (UEG) and European Society for Neurogastroenterology and Motility (ESNM) consensus on gastroparesis. Neurogastroenterol Motil. 2021 Aug;33(8):e14237. doi: 10.1111/nmo.14237. PMID 34399024
  • Pasricha PJ, Grover M, Yates KP, Abell TL, Bernard CE, Koch KL, McCallum RW, Sarosiek I, Kuo B, Bulat R, Chen J, Shulman RJ, Lee L, Tonascia J, Miriel LA, Hamilton F, Farrugia G, Parkman HP; National Institute of Diabetes and Digestive and Kidney Diseases/National Institutes of Health Gastroparesis Clinical Research Consortium. Functional Dyspepsia and Gastroparesis in Tertiary Care are Interchang PMID 33548234
  • Pasricha PJ, Colvin R, Yates K, Hasler WL, Abell TL, Unalp-Arida A, Nguyen L, Farrugia G, Koch KL, Parkman HP, Snape WJ, Lee L, Tonascia J, Hamilton F. Characteristics of patients with chronic unexplained nausea and vomiting and normal gastric emptying. Clin Gastroenterol Hepatol. 2011 Jul;9(7):567-76.e1-4. doi: 10.1016/j.cgh.2011.03.003. Epub 2011 Mar 11. PMID 21397732
  • Makarov OV, Khashchukoeva AZ, Borisenko SA, Epeikina TN, Moiseeva NB. [Immunologic aspects of ovarian tumors]. Akush Ginekol (Mosk). 1988 Nov;(11):3-6. No abstract available. Russian. PMID 3071162
  • Vijayvargiya P, Jameie-Oskooei S, Camilleri M, Chedid V, Erwin PJ, Murad MH. Association between delayed gastric emptying and upper gastrointestinal symptoms: a systematic review and meta-analysis. Gut. 2019 May;68(5):804-813. doi: 10.1136/gutjnl-2018-316405. Epub 2018 Jun 2. PMID 29860241

Identifiers

NCT: NCT05846802 · 14-DK-GpR4 · U01DK073975 · U01DK074035 · U01DK074007 · U24DK074008 · U01DK073983 · U01DK112193 · U01DK073974 · IRB00401119

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗