Registry for patients with gastroparesis and functional dyspepsia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The Gastroparesis Registry 4 is an observational study that aims to gather comprehensive data on patients experiencing symptoms of gastroparesis and functional dyspepsia. Participants will undergo a series of assessments, including questionnaires, a nutrient drink test, and a gastric emptying study, to evaluate their symptoms and clinical characteristics. The study will focus on understanding the similarities and differences in clinical, pathophysiological, and psychological aspects of these gastrointestinal disorders over a period of 48 weeks.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Jay Pasricha, MD — Mayo Clinic
• Study coordinator: Laura Miriel
• Email: lmiriel1@jhu.edu
• Phone: 4435024165

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Gastric-focused ultrasound to see if it changes stomach activity and symptoms

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.