GastroparesisPGpR2NCT05981300
GpCRC Pediatric Gastroparesis Registry 2
An observational study of Gastroparesis and Gastroparesis-like Syndrome, run by Johns Hopkins Bloomberg School of Public Health at 6 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 8 to 25 years
- Conditions the study is for
- Gastroparesis, Gastroparesis-like Syndrome
- How many people
- 216 participants
- Where
- 6 sitesUnited States
- Study dates
- 18 Dec 2024to 30 Apr 2027
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study population will be 216 participants aged 8-25 years of age with symptoms of Gp located in the United States.
Who may be able to join
- 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:
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Nir Bar, MD, 617-609-9393, nbar@mgh.harvard.edu
Anna Borodianski, (617) 724-0480, aborodianski@mgh.harvard.edu
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Samuel Nurko, MD, 617-355-6055, Samuel.Nurko@childrens.harvard.edu
Elise Delaney, 617-355-6055, Elise.Delaney@childrens.harvard.edu
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Amina Usman, MD, Amina.Usman@nationwidechildrens.org
Peter Lu, Peter.Lu@nationwidechildrens.org
- Recruiting
Texas Tech University Health Science Center
El Paso, Texas, 79905
Denease Francis, MD, 915-215-5042, denease.francis@ttuhsc.edu
Denise Vasquez, 915-214-4388, denise.vasquez@ttuhsc.edu
- Recruiting
Baylor College of Medicine/Texas Children's Hospital
Houston, Texas, 77030
Geoffrey A Preidis, MD, PhD, 832-822-3617, geoffrey.preidis@bcm.edu
Heather Charron, 713-798-0381, charron@bcm.edu
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Katja Karrento, MD, 414-266-3690, kkarrento@mcw.edu
Taryn Steberl, (262) 336-5233, tsteberl@mcw.edu
About this study
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
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).
Read the 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.
- Conditions
- Gastroparesis, Gastroparesis-like Syndrome
- Keywords
- Functional Disorder of Gastrointestinal Tract, Gastro-Intestinal Disorder
- Medical subject headings
- Gastroparesis, Gastrointestinal Diseases, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 48 weeks
Secondary outcomes (3)
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.
Measured: Baseline
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.
Measured: Baseline, 48 weeks
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.
Measured: Baseline, 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start18 Dec 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (99)Papers the sponsor has linked to this study.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 216 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- 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, Children's Wisconsin, Boston Children's Hospital, Nationwide Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Geoffrey Preidis, MD, PhD, Study chair, Baylor College of MedicineDavid Shade, JD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05981300
- Sponsor's protocol ID
- 15-DK-PGpR2
- Other IDs
- U01DK112194, U01DK112193, U01DK074035, U24DK074008, IRB00416909
- Acronym
- PGpR2
- Status last verified
- Mar 2026
- First submitted
- 1 Aug 2023
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The type(s) of supporting information that will be shared include deidentified individual participant data set and data dictionaries.
Publications
Pasricha PJ, Grover M, Yates KP, Abell TL, Bernard CE, Koch KL, McCallum RW, Sarosiek I, Kuo B, Bulat R, Chen J, Shulman RJ, Lee L, Tonascia J, Miriel LA, Hamilton F, Farrugia G, Parkman HP; National Institute of Diabetes and Digestive and Kidney Diseases/National Institutes of Health Gastroparesis Clinical Research Consortium. Functional Dyspepsia and Gastroparesis in Tertiary Care are Interchangeable Syndromes With Common Clinical and Pathologic Features. Gastroenterology. 2021 May;160(6):2006-2017. doi: 10.1053/j.gastro.2021.01.230. Epub 2021 Feb 3.
PubMed 33548234Waseem S, Islam S, Kahn G, Moshiree B, Talley NJ. Spectrum of gastroparesis in children. J Pediatr Gastroenterol Nutr. 2012 Aug;55(2):166-72. doi: 10.1097/MPG.0b013e31824cf06e.
PubMed 22314391Rodriguez L, Irani K, Jiang H, Goldstein AM. Clinical presentation, response to therapy, and outcome of gastroparesis in children. J Pediatr Gastroenterol Nutr. 2012 Aug;55(2):185-90. doi: 10.1097/MPG.0b013e318248ed3f.
PubMed 22228004Rapkin AJ, Tsao JC, Turk N, Anderson M, Zeltzer LK. Relationships among self-rated tanner staging, hormones, and psychosocial factors in healthy female adolescents. J Pediatr Adolesc Gynecol. 2006 Jun;19(3):181-7. doi: 10.1016/j.jpag.2006.02.004.
PubMed 16731411Sizonenko PC, Aubert ML. Neuroendocrine changes characteristic of sexual maturation. J Neural Transm Suppl. 1986;21:159-81.
PubMed 3462329Angold A, Costello EJ. Depressive comorbidity in children and adolescents: empirical, theoretical, and methodological issues. Am J Psychiatry. 1993 Dec;150(12):1779-91. doi: 10.1176/ajp.150.12.1779.
PubMed 8238631Parkman HP, Yates K, Hasler WL, Nguyen L, Pasricha PJ, Snape WJ, Farrugia G, Koch KL, Abell TL, McCallum RW, Lee L, Unalp-Arida A, Tonascia J, Hamilton F; National Institute of Diabetes and Digestive and Kidney Diseases Gastroparesis Clinical Research Consortium. Clinical features of idiopathic gastroparesis vary with sex, body mass, symptom onset, delay in gastric emptying, and gastroparesis severity. Gastroenterology. 2011 Jan;140(1):101-15. doi: 10.1053/j.gastro.2010.10.015. Epub 2010 Oct 20.
PubMed 20965184Thapar N, Benninga MA, Crowell MD, Di Lorenzo C, Mack I, Nurko S, Saps M, Shulman RJ, Szajewska H, van Tilburg MAL, Enck P. Paediatric functional abdominal pain disorders. Nat Rev Dis Primers. 2020 Nov 5;6(1):89. doi: 10.1038/s41572-020-00222-5.
PubMed 33154368Camilleri M. Novel Diet, Drugs, and Gastric Interventions for Gastroparesis. Clin Gastroenterol Hepatol. 2016 Aug;14(8):1072-80. doi: 10.1016/j.cgh.2015.12.033. Epub 2016 Jan 4.
PubMed 26762845Islam S. Gastroparesis in children. Curr Opin Pediatr. 2015 Jun;27(3):377-82. doi: 10.1097/MOP.0000000000000216.
PubMed 25944312Camilleri M, Parkman HP, Shafi MA, Abell TL, Gerson L; American College of Gastroenterology. Clinical guideline: management of gastroparesis. Am J Gastroenterol. 2013 Jan;108(1):18-37; quiz 38. doi: 10.1038/ajg.2012.373. Epub 2012 Nov 13.
PubMed 23147521Pasricha PJ, Parkman HP. Gastroparesis: definitions and diagnosis. Gastroenterol Clin North Am. 2015 Mar;44(1):1-7. doi: 10.1016/j.gtc.2014.11.001. Epub 2014 Dec 24.
PubMed 25667018Lacy BE, Tack J, Gyawali CP. AGA Clinical Practice Update on Management of Medically Refractory Gastroparesis: Expert Review. Clin Gastroenterol Hepatol. 2022 Mar;20(3):491-500. doi: 10.1016/j.cgh.2021.10.038. Epub 2021 Oct 29.
PubMed 34757197Vijayvargiya P, Jameie-Oskooei S, Camilleri M, Chedid V, Erwin PJ, Murad MH. Association between delayed gastric emptying and upper gastrointestinal symptoms: a systematic review and meta-analysis. Gut. 2019 May;68(5):804-813. doi: 10.1136/gutjnl-2018-316405. Epub 2018 Jun 2.
PubMed 29860241Febo-Rodriguez L, Chumpitazi BP, Musaad S, Sher AC, Shulman RJ. Meal-Induced Symptoms in Children with Dyspepsia-Relationships to Sex and the Presence of Gastroparesis. J Pediatr. 2021 Apr;231:117-123. doi: 10.1016/j.jpeds.2020.12.048. Epub 2020 Dec 23.
PubMed 33359472
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05981300
- Acronym / sponsor ID
- PGpR2 / 15-DK-PGpR2
- Conditions
- Gastroparesis, Gastroparesis-like Syndrome
- Keywords
- Functional Disorder of Gastrointestinal Tract, Gastro-Intestinal Disorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- 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, Children's Wisconsin, Boston Children's Hospital, Nationwide Children's Hospital
- Study start
- 18 Dec 2024 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 8 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population will be 216 participants aged 8-25 years of age with symptoms of Gp located in the United States.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Presence or absence of Carnett's sign as assessed by abdominal examination
Time frame: Baseline
Change in volume (mL) of liquid consumed as assessed by the Water Load Satiety Test
Time frame: Baseline, 48 weeks
Change in Pain Catastrophizing Scale scores (PCS)
Time frame: Baseline, 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Background: PubMed 33548234Pasricha PJ, Grover M, Yates KP, Abell TL, Bernard CE, Koch KL, McCallum RW, Sarosiek I, Kuo B, Bulat R, Chen J, Shulman RJ, Lee L, Tonascia J, Miriel LA, Hamilton F, Farrugia G, Parkman HP; National Institute of Diabetes and Digestive and Kidney Diseases/National Institutes of Health Gastroparesis Clinical Research Consortium. Functional Dyspepsia and Gastroparesis in Tertiary Care are Interchangeable Syndromes With Common Clinical and Pathologic Features. Gastroenterology. 2021 May;160(6):2006-2017. doi: 10.1053/j.gastro.2021.01.230. Epub 2021 Feb 3.
- Background: PubMed 22314391Waseem S, Islam S, Kahn G, Moshiree B, Talley NJ. Spectrum of gastroparesis in children. J Pediatr Gastroenterol Nutr. 2012 Aug;55(2):166-72. doi: 10.1097/MPG.0b013e31824cf06e.
- Background: PubMed 22228004Rodriguez L, Irani K, Jiang H, Goldstein AM. Clinical presentation, response to therapy, and outcome of gastroparesis in children. J Pediatr Gastroenterol Nutr. 2012 Aug;55(2):185-90. doi: 10.1097/MPG.0b013e318248ed3f.
- Background: PubMed 16731411Rapkin AJ, Tsao JC, Turk N, Anderson M, Zeltzer LK. Relationships among self-rated tanner staging, hormones, and psychosocial factors in healthy female adolescents. J Pediatr Adolesc Gynecol. 2006 Jun;19(3):181-7. doi: 10.1016/j.jpag.2006.02.004.
- Background: PubMed 3462329Sizonenko PC, Aubert ML. Neuroendocrine changes characteristic of sexual maturation. J Neural Transm Suppl. 1986;21:159-81.
- Background: PubMed 8238631Angold A, Costello EJ. Depressive comorbidity in children and adolescents: empirical, theoretical, and methodological issues. Am J Psychiatry. 1993 Dec;150(12):1779-91. doi: 10.1176/ajp.150.12.1779.
- Background: PubMed 20965184Parkman HP, Yates K, Hasler WL, Nguyen L, Pasricha PJ, Snape WJ, Farrugia G, Koch KL, Abell TL, McCallum RW, Lee L, Unalp-Arida A, Tonascia J, Hamilton F; National Institute of Diabetes and Digestive and Kidney Diseases Gastroparesis Clinical Research Consortium. Clinical features of idiopathic gastroparesis vary with sex, body mass, symptom onset, delay in gastric emptying, and gastroparesis severity. Gastroenterology. 2011 Jan;140(1):101-15. doi: 10.1053/j.gastro.2010.10.015. Epub 2010 Oct 20.
- Background: PubMed 33154368Thapar N, Benninga MA, Crowell MD, Di Lorenzo C, Mack I, Nurko S, Saps M, Shulman RJ, Szajewska H, van Tilburg MAL, Enck P. Paediatric functional abdominal pain disorders. Nat Rev Dis Primers. 2020 Nov 5;6(1):89. doi: 10.1038/s41572-020-00222-5.
- Background: PubMed 26762845Camilleri M. Novel Diet, Drugs, and Gastric Interventions for Gastroparesis. Clin Gastroenterol Hepatol. 2016 Aug;14(8):1072-80. doi: 10.1016/j.cgh.2015.12.033. Epub 2016 Jan 4.
- Background: PubMed 25944312Islam S. Gastroparesis in children. Curr Opin Pediatr. 2015 Jun;27(3):377-82. doi: 10.1097/MOP.0000000000000216.
- Background: PubMed 23147521Camilleri M, Parkman HP, Shafi MA, Abell TL, Gerson L; American College of Gastroenterology. Clinical guideline: management of gastroparesis. Am J Gastroenterol. 2013 Jan;108(1):18-37; quiz 38. doi: 10.1038/ajg.2012.373. Epub 2012 Nov 13.
- Background: PubMed 25667018Pasricha PJ, Parkman HP. Gastroparesis: definitions and diagnosis. Gastroenterol Clin North Am. 2015 Mar;44(1):1-7. doi: 10.1016/j.gtc.2014.11.001. Epub 2014 Dec 24.
- Individual participant dataSharing planned: Yes. The type(s) of supporting information that will be shared include deidentified individual participant data set and data dictionaries.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Geoffrey Preidis, MD, PhD study chair
Baylor College of Medicine
David Shade, JD principal investigator
Johns Hopkins Bloomberg School of Public Health
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroparesis and Gastroparesis-like Syndrome, run by Johns Hopkins Bloomberg School of Public Health at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Miriel (410-955-4165, laura.miriel@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05981300, which also lists 99 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.