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GpCRC Pediatric Gastroparesis Registry 2 (PGpR2)

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ClinicalTrials.gov Identifier: NCT05981300
Recruitment Status : Not yet recruiting
First Posted : August 8, 2023
Last Update Posted : May 9, 2024
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Texas Tech University Health Sciences Center, El Paso
Baylor College of Medicine
Massachusetts General Hospital
Medical College of Wisconsin
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

Study Description
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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).

Condition or disease
Gastroparesis Gastroparesis-like Syndrome

Detailed 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.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 216 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
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
Estimated Study Start Date : June 1, 2024
Estimated Primary Completion Date : December 1, 2026
Estimated Study Completion Date : June 1, 2027

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Ages 8-25 with delayed gastric emptying
Participants aged 8-25 with delayed gastric emptying of solids based on gastric emptying scintigraphy
Ages 8-25 with normal gastric emptying
Participants aged 8-25 with normal gastric emptying of solids based on gastric emptying scintigraphy


Outcome Measures
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Primary Outcome Measures :
  1. 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™ [ Time Frame: Baseline, 48 weeks ]
    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.


Secondary Outcome Measures :
  1. Presence or absence of Carnett's sign as assessed by abdominal examination [ Time Frame: 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.


  2. Change in volume (mL) of liquid consumed as assessed by the Water Load Satiety Test [ Time Frame: Baseline, 48 weeks ]
    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.

  3. Change in Pain Catastrophizing Scale scores (PCS) [ Time Frame: Baseline, 48 weeks ]
    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.


Biospecimen Retention:   Samples Without DNA
Plasma and serum.

Eligibility Criteria
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Ages Eligible for Study:   8 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will be 216 participants aged 8-25 years of age with symptoms of Gp located in the United States.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05981300


Contacts
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Contact: Laura Miriel 410-955-4165 laura.miriel@jhu.edu
Contact: Peggy Adamo 410-502-9137 madamo1@jhu.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Contact: Samuel Nurko, MD    617-355-6055    Samuel.Nurko@childrens.harvard.edu   
Contact: Chris Chalmers    (857) 218-5098    Christopher.Chalmers@childrens.harvard.edu   
Principal Investigator: Samuel Nurko, MD         
Sub-Investigator: Rachel Rosen, MD         
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Contact: Amina Usman, MD       Amina.Usman@nationwidechildrens.org   
Contact: Peter Lu       Peter.Lu@nationwidechildrens.org   
Sub-Investigator: Kent Williams, MD         
Principal Investigator: Peter Lu, MD         
United States, Texas
Texas Tech University Health Science Center
El Paso, Texas, United States, 79905
Baylor College of Medicine/Texas Children's Hospital
Houston, Texas, United States, 77030
Contact: Robert J Shulman, MD    713-798-7145    rshulman@bcm.edu   
Contact: Heather Charron    713-798-0381    charron@bcm.edu   
Principal Investigator: Robert J Shulman, MD         
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Contact: Katja Karrento, MD    414-266-3690    kkarrento@mcw.edu   
Contact: Mychoua Vang       myvang@mcw.edu   
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Texas Tech University Health Sciences Center, El Paso
Baylor College of Medicine
Massachusetts General Hospital
Medical College of Wisconsin
Investigators
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Study Chair: Robert J Shulman, MD Baylor College of Medicine
Principal Investigator: James Tonascia, PhD Johns Hopkins Bloomberg School of Public Health
More Information
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Publications:
Walker LS, Caplan-Dover A, Rasquin-Weber A. Manual for the Questionnaire on Pediatric Gastrointestinal Disorders. Nashville: Vanderbilt University School of Medicine, 2000.
Spielberger CD. Manual for the State-Trait Anxiety Inventory for Children. Palo Alto: Consulting Psychologists Press, 1973.
PASS 2023 Power Analysis and Sample Size Software (2023). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass

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Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT05981300    
Other Study ID Numbers: 15-DK-PGpR2
U01DK112194 ( U.S. NIH Grant/Contract )
U01DK112193 ( U.S. NIH Grant/Contract )
U01DK074035 ( U.S. NIH Grant/Contract )
U24DK074008 ( U.S. NIH Grant/Contract )
First Posted: August 8, 2023    Key Record Dates
Last Update Posted: May 9, 2024
Last Verified: May 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins Bloomberg School of Public Health:
Functional Disorder of Gastrointestinal Tract
Gastro-Intestinal Disorder
Additional relevant MeSH terms:
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Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Paralysis
Neurologic Manifestations