NCT05981300 GpCRC Pediatric Gastroparesis Registry 2
| NCT ID | NCT05981300 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins Bloomberg School of Public Health |
| Condition | Gastroparesis |
| Study Type | OBSERVATIONAL |
| Enrollment | 216 participants |
| Start Date | 2024-12-18 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 216 participants in total. It began in 2024-12-18 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
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.
Contact & Investigator
Geoffrey Preidis, MD, PhD
STUDY CHAIR
Baylor College of Medicine
Frequently Asked Questions
Who can join the NCT05981300 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 25 Years, studying Gastroparesis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05981300 currently recruiting?
Yes, NCT05981300 is actively recruiting participants. Contact the research team at laura.miriel@jhu.edu for enrollment information.
Where is the NCT05981300 trial being conducted?
This trial is being conducted at Boston, United States, Boston, United States, Columbus, United States, El Paso, United States and 2 additional locations.
Who is sponsoring the NCT05981300 clinical trial?
NCT05981300 is sponsored by Johns Hopkins Bloomberg School of Public Health. The principal investigator is Geoffrey Preidis, MD, PhD at Baylor College of Medicine. The trial plans to enroll 216 participants.