GpCRC Pediatric Gastroparesis Registry 2

Last updated: January 21, 2025
Sponsor: Johns Hopkins Bloomberg School of Public Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastroparesis

Treatment

N/A

Clinical Study ID

NCT05981300
15-DK-PGpR2
U01DK112193
U01DK112194
U24DK074008
U01DK074035
IRB00416909
  • Ages 8-25
  • All Genders

Study 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

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

Total Participants: 216
Study Start date:
December 18, 2024
Estimated Completion Date:
June 30, 2027

Study 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.

Connect with a study center

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Nationwide Children's Hospital

    Columbus, Ohio 43205
    United States

    Site Not Available

  • Texas Tech University Health Science Center

    El Paso, Texas 79905
    United States

    Active - Recruiting

  • Baylor College of Medicine/Texas Children's Hospital

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.