Phase
Condition
Gastroparesis
Treatment
N/AClinical Study ID
Ages 8-25 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 theduration 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 EggBeaters protocol (or equivalent generic liquid egg white meal) within the last 12months 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 thisstudy as GLS) or have previously participated in the Pediatric GastroparesisRegistry (PGpR) study
An etiology of either diabetic or idiopathic Gp or GLS
Exclusion
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 ofinability to complete questionnaires)
Use of narcotic analgesics greater than three days per week.
Presence of conditions associated with GI mucosal disease (e.g., inflammatory boweldisease, known eosinophilic gastroenteritis or eosinophilic esophagitis, gastriculcer, peptic ulcer, celiac disease)
Presence of any other condition that could case delayed gastric emptying
Gastrointestinal construction confirmed by upper endoscopy (EGD), uppergastrointestinal series (UGI), or abdominal CT
Primary neurological conditions that can cause nausea and vomiting such as increasedintracranial pressure, space occupying or inflammatory/infectious legions
Acute or chronic renal failure (abnormal creatinine for age) and /or on hemodialysisor peritoneal dialysis
Acute liver failure
Advanced liver disease (features of portal hypertension)
Clinically significant congenital heart disease (i.e., vaginal injury during cardiacrepair)
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 thesymptoms or could interfere with study requirements.
Study Design
Study Description
Connect with a study center
Boston Children's Hospital
Boston, Massachusetts 02115
United StatesActive - Recruiting
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
Nationwide Children's Hospital
Columbus, Ohio 43205
United StatesSite Not Available
Texas Tech University Health Science Center
El Paso, Texas 79905
United StatesActive - Recruiting
Baylor College of Medicine/Texas Children's Hospital
Houston, Texas 77030
United StatesActive - Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesActive - Recruiting
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