GpCRC Pediatric Gastroparesis Registry 2

Gastroparesis Clinical Trial

— PGpR2  

Official title:

GpCRC Pediatric Gastroparesis Registry 2: Characterization and Clinical Course of Symptoms and Gastric Emptying in Pediatric, Adolescent, and Young Adult Participants With Symptoms of Gastroparesis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05981300
• Other study ID #: 15-DK-PGpR2
• Secondary ID: U01DK112194U01DK
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: June 1, 2027

Study information

• Verified date: May 2024
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: Laura Miriel
• Phone: 410-955-4165
• Email: laura.miriel[@]jhu.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The objective of the Pediatric Gastroparesis Registry 2 is to create a national prospective registry of children, adolescents, and young adults with gastroparesis and gastroparesis-like syndrome (symptoms of gastroparesis but normal gastric emptying).

Description:

An observational study to investigate the natural history and clinical course of children, adolescents, and young adults with symptoms of gastroparesis (e.g., nausea, vomiting, abdominal pain, bloating, distention) 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 participants and their clinical course.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 216
• Est. completion date: June 1, 2027
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 25 Years

Eligibility

Inclusion Criteria:

• Provision of signed and dated informed consent form and assent, as age appropriate.
• Stated willingness to comply with all study procedures and availability for the duration of the study
• 8 to 25 years of age at the time of enrollment
• Symptoms of Gp of at least 12 weeks duration: constellation of some combination of:

nausea, vomiting, early satiety, postprandial fullness; symptoms sometimes may be accompanied by upper abdominal pain

• Have undergone a gastric emptying scintigraphic study of solids using 4-hour Egg Beaters protocol (or equivalent generic liquid egg white meal) within the last 12

months who fall into one of the two categories:

• Delayed gastric emptying-defined as an abnormal 2-hour (>60% retention) and/or 4- hour (>10% retention) result based on a 4-hour scintigraphic gastric emptying study
• Gastric emptying that is not delayed but who have symptoms of Gp (designated in this study as GLS) or have previously participated in the Pediatric Gastroparesis Registry (PGpR) study
• An etiology of either diabetic or idiopathic Gp or GLS

Exclusion Criteria:

• Inability to comply with or complete the scintigraphic gastric emptying test (including allergy to eggs)
• Pregnancy
• Autism spectrum disorder, significant developmental delay, psychosis (because of inability to complete questionnaires)
• Use of narcotic analgesics greater than three days per week.
• Presence of conditions associated with GI mucosal disease (e.g., inflammatory bowel disease, known eosinophilic gastroenteritis or eosinophilic esophagitis, gastric ulcer, peptic ulcer, celiac disease)
• Presence of any other condition that could case delayed gastric emptying
• Gastrointestinal construction confirmed by upper endoscopy (EGD), upper gastrointestinal series (UGI), or abdominal CT
• Primary neurological conditions that can cause nausea and vomiting such as increased intracranial pressure, space occupying or inflammatory/infectious legions
• Acute or chronic renal failure (abnormal creatinine for age) and /or on hemodialysis or peritoneal dialysis
• Acute liver failure
• Advanced liver disease (features of portal hypertension)
• Clinically significant congenital heart disease (i.e., vaginal injury during cardiac repair)
• History of esophageal, gastric or bowel surgery.
• Metabolic disease including mitochondrial disease and inborn errors of metabolism
• Chronic lung disease (including cystic fibrosis)
• A serious chronic medical condition (e.g., inflammatory bowel disease)
• Use of medications that can affect motility during the gastric emptying study
• Any other condition, which in the option of the investigator, could explain the symptoms or could interfere with study requirements.

Related Conditions & MeSH terms

• Gastroparesis
• Gastroparesis-like Syndrome

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Texas Tech University Health Science Center	El Paso	Texas
United States	Baylor College of Medicine/Texas Children's Hospital	Houston	Texas
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (6)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Baylor College of Medicine, Massachusetts General Hospital, Medical College of Wisconsin, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Texas Tech University Health Sciences Center, El Paso

Country where clinical trial is conducted

United States, 

References & Publications (99)

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Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean symptom severity of gastrointestinal symptoms using the change in total score from the Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Scales™	The PedsQL™ GI Symptoms Scales questionnaire has 65 response items covering 10 dimensions, with each item offered as a better-to-worse 5-point Likert scale choice: 0=never, 1=almost never, 2=sometimes, 3=often, 4=almost always. The item responses are transformed to a worse-to-better order and rescaled to 0-100: 0=almost always, 25= often, 50=sometimes, 75=almost never, 100= never, with higher scores indicating better health-related quality of life (HRQOL) and fewer problems or symptoms.he per-participant PedsQL™ GI Symptoms Scales total score is the sum of the 65 transformed and rescaled item responses. The primary outcome measure is the arithmetic mean of the 65 transformed item responses and is repeated at baseline and 48 weeks for each participant.	Baseline, 48 weeks
Secondary	Presence or absence of Carnett's sign as assessed by abdominal examination	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.	Baseline
Secondary	Change in volume (mL) of liquid consumed as assessed by the Water Load Satiety Test	Change from baseline to 48 weeks in amount of liquid (mL) consumed during the Water Load Satiety Test (WLST) Lower volumes are signs of impaired accommodation.	Baseline, 48 weeks
Secondary	Change in Pain Catastrophizing Scale scores (PCS)	The outcome is assessed using change in the total score at 48-weeks minus the baseline score. A negative change indicates reduced pain catastrophizing. PCS total score is computed by summing responses to all 13 items. PCS total scores range from 0 - 52.	Baseline, 48 weeks