GpR4: Gastroparesis Registry 4

Sponsor

Johns Hopkins Bloomberg School of Public Health (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05846802

Collaborator

Texas Tech University Health Sciences Center, El Paso (Other), Temple University (Other), University of Louisville (Other), Mayo Clinic (Other), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH), Massachusetts General Hospital (Other), Wake Forest University (Other)

250

Enrollment

Locations

Anticipated Duration (Months)

41.7

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

250 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2026

Anticipated Study Completion Date :

Jun 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Gastroparesis Gastroparesis symptoms with delayed emptying
Functional Dyspepsia Gastroparesis symptoms without delayed emptying

Outcome Measures

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. [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

Secondary Outcome Measures

Changes in gastric emptying, as measured by gastric emptying scintigraphy (GES) at baseline and 48 weeks [Baseline, 48 weeks]
Changes in gastric emptying, as measured by gastric emptying scintigraphy (GES) at baseline and 48 weeks. Normal values for gastric emptying scintigraphy have been established in earlier studies using healthy volunteers. Gastric retention of 99mTc > 60% at 2 hours and/or > 10% at 4 hours is considered evidence of delayed gastric emptying of solids.

Other Outcome Measures

Presence or absence of Carnett's sign for abdominal wall pain at baseline. [Baseline]
Presence or absence Carnett's sign for abdominal wall pain at baseline. Carnett's sign is a finding on clinical examination in which (acute) abdominal pain remains unchanged or increases when the muscles of the abdominal wall are tensed. As part of the abdominal examination, the patient is asked to lift the head and shoulders from the examination table to tense the abdominal muscles. An alternative is to ask the patient to raise both legs with straight knees. A positive test indicates the increased likelihood that the abdominal wall and not the abdominal cavity is the source of the pain (for example, due to rectus sheath hematoma instead of appendicitis). A negative Carnett's sign is said to occur when the abdominal pain decreases when the patient is asked to lift the head; this points to an intra-abdominal cause of the pain

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 6 months
Negative upper endoscopy or upper radiographic GI series within 2 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jay Pasricha	Scottsdale	Arizona	United States	85259
2	University of Louisville	Louisville	Kentucky	United States	40202
3	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
4	Kenneth Koch	Winston-Salem	North Carolina	United States	27157
5	Temple University Hospital	Philadelphia	Pennsylvania	United States	19140
6	Texas Tech University Health Science Center (TTUHSC)	El Paso	Texas	United States	79905