Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
RECRUITING
Total Enrollment
216 participants
Study Classification
OBSERVATIONAL
Study Start Date
2024-12-18
Study Completion Date
2027-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Jejunal Feeding Via Gastrojejunal Tube in Refractory Gastroesophageal Reflux
NCT05278689
Gastroesophageal Reflux
UNKNOWN
Pediatric Blunt Abdominal Trauma Clinical Prediction Model
NCT02206698
Pediatric Abdominal Trauma
COMPLETED
Pediatric Acute Gastrointestinal Bleeding Registry
NCT03090945
Upper Gastrointestinal Bleeding
Gastro Intestinal Bleeding
UNKNOWN
Vanderbilt Childhood Obesity Registry
NCT02957916
Childhood Onset Obesity
Pediatric Obesity
Childhood Obesity
ACTIVE_NOT_RECRUITING
Necrotizing Enterocolitis (NEC) Surgical Database
NCT00120159
Necrotizing Enterocolitis
UNKNOWN
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Gastroparesis
Gastroparesis-like Syndrome
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ages 8-25 with delayed gastric emptying
Participants aged 8-25 with delayed gastric emptying of solids based on gastric emptying scintigraphy
No interventions assigned to this group
Ages 8-25 with normal gastric emptying
Participants aged 8-25 with normal gastric emptying of solids based on gastric emptying scintigraphy
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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
* 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.
* 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.
Minimum Eligible Age
8 Years
Maximum Eligible Age
25 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Sponsor Role
collaborator
Texas Tech University Health Sciences Center, El Paso
OTHER
Sponsor Role
collaborator
Baylor College of Medicine
OTHER
Sponsor Role
collaborator
Massachusetts General Hospital
OTHER
Sponsor Role
collaborator
Children's Wisconsin
UNKNOWN
Sponsor Role
collaborator
Boston Children's Hospital
OTHER
Sponsor Role
collaborator
Nationwide Children's Hospital
OTHER
Sponsor Role
collaborator
Johns Hopkins Bloomberg School of Public Health
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Geoffrey Preidis, MD, PhD
Role: STUDY_CHAIR
Baylor College of Medicine
David Shade, JD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins Bloomberg School of Public Health
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Massachusetts General Hospital
Boston, Massachusetts, United States
Site Status
RECRUITING
Boston Children's Hospital
Boston, Massachusetts, United States
Site Status
RECRUITING
Nationwide Children's Hospital
Columbus, Ohio, United States
Site Status
RECRUITING
Texas Tech University Health Science Center
El Paso, Texas, United States
Site Status
RECRUITING
Baylor College of Medicine/Texas Children's Hospital
Houston, Texas, United States
Site Status
RECRUITING
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
United States
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
BACKGROUND
Waseem 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.
Reference Type
BACKGROUND
Rodriguez 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.
Reference Type
BACKGROUND
Rapkin 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.
Reference Type
BACKGROUND
Sizonenko PC, Aubert ML. Neuroendocrine changes characteristic of sexual maturation. J Neural Transm Suppl. 1986;21:159-81.
Reference Type
BACKGROUND
Angold 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.
Reference Type
BACKGROUND
Parkman 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.
Reference Type
BACKGROUND
Thapar 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.
Reference Type
BACKGROUND
Camilleri 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.
Reference Type
BACKGROUND
Islam S. Gastroparesis in children. Curr Opin Pediatr. 2015 Jun;27(3):377-82. doi: 10.1097/MOP.0000000000000216.
Reference Type
BACKGROUND
Camilleri 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.
Reference Type
BACKGROUND
Pasricha 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.
Reference Type
BACKGROUND
Lacy 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.
Reference Type
BACKGROUND
Vijayvargiya 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.
Reference Type
BACKGROUND
Febo-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.
Reference Type
BACKGROUND
Cangemi DJ, Lacy BE. Gastroparesis. Curr Opin Gastroenterol. 2021 Nov 1;37(6):596-601. doi: 10.1097/MOG.0000000000000782.
Reference Type
BACKGROUND
Febo-Rodriguez L, Chumpitazi BP, Shulman RJ. Childhood gastroparesis is a unique entity in need of further investigation. Neurogastroenterol Motil. 2020 Mar;32(3):e13699. doi: 10.1111/nmo.13699. Epub 2019 Aug 13.
Reference Type
BACKGROUND
Drossman DA, Hasler WL. Rome IV-Functional GI Disorders: Disorders of Gut-Brain Interaction. Gastroenterology. 2016 May;150(6):1257-61. doi: 10.1053/j.gastro.2016.03.035. No abstract available.
Reference Type
BACKGROUND
Saps M, Seshadri R, Sztainberg M, Schaffer G, Marshall BM, Di Lorenzo C. A prospective school-based study of abdominal pain and other common somatic complaints in children. J Pediatr. 2009 Mar;154(3):322-6. doi: 10.1016/j.jpeds.2008.09.047. Epub 2008 Nov 28.
Reference Type
BACKGROUND
Everhart JE, Ruhl CE. Burden of digestive diseases in the United States part II: lower gastrointestinal diseases. Gastroenterology. 2009 Mar;136(3):741-54. doi: 10.1053/j.gastro.2009.01.015. Epub 2009 Jan 21. No abstract available.
Reference Type
BACKGROUND
Everhart JE, Ruhl CE. Burden of digestive diseases in the United States part I: overall and upper gastrointestinal diseases. Gastroenterology. 2009 Feb;136(2):376-86. doi: 10.1053/j.gastro.2008.12.015. Epub 2009 Jan 3. No abstract available.
Reference Type
BACKGROUND
Park R, Mikami S, LeClair J, Bollom A, Lembo C, Sethi S, Lembo A, Jones M, Cheng V, Friedlander E, Nurko S. Inpatient burden of childhood functional GI disorders in the USA: an analysis of national trends in the USA from 1997 to 2009. Neurogastroenterol Motil. 2015 May;27(5):684-92. doi: 10.1111/nmo.12542. Epub 2015 Mar 22.
Reference Type
BACKGROUND
Mani J, Madani S, Thomas R. Economic Impact and Prognostic Factors of Functional Dyspepsia in Children. J Pediatr Gastroenterol Nutr. 2020 Apr;70(4):e65-e70. doi: 10.1097/MPG.0000000000002599.
Reference Type
BACKGROUND
Hyams JS, Di Lorenzo C, Saps M, Shulman RJ, Staiano A, van Tilburg M. Functional Disorders: Children and Adolescents. Gastroenterology. 2016 Feb 15:S0016-5085(16)00181-5. doi: 10.1053/j.gastro.2016.02.015. Online ahead of print.
Reference Type
BACKGROUND
Turco R, Russo M, Martinelli M, Castiello R, Coppola V, Miele E, Staiano A. Do Distinct Functional Dyspepsia Subtypes Exist in Children? J Pediatr Gastroenterol Nutr. 2016 Mar;62(3):387-92. doi: 10.1097/MPG.0000000000000944.
Reference Type
BACKGROUND
Taft TH, Doerfler B, Edlynn E, Nguyen L. The Scarcity of Literature on the Psychological, Social, and Emotional Effects of Gastroparesis in Children. Children (Basel). 2020 Aug 31;7(9):115. doi: 10.3390/children7090115.
Reference Type
BACKGROUND
Varni JW, Shulman RJ, Self MM, Febo-Rodriguez L, Charron H, Williams K, Nurko S, Rosen RL, Chumpitazi BP; Gastroparesis Research Consortium (GpCRC). PedsQL Gastroparesis Symptoms Module Domain and Item Development: Qualitative Methods. J Pediatr Gastroenterol Nutr. 2021 Aug 1;73(2):192-196. doi: 10.1097/MPG.0000000000003146.
Reference Type
BACKGROUND
Colombo JM, Deacy AD, Schurman JV, Friesen CA. Heartburn in children and adolescents in the presence of functional dyspepsia and/or irritable bowel syndrome correlates with the presence of sleep disturbances, anxiety, and depression. Medicine (Baltimore). 2021 Apr 2;100(13):e25426. doi: 10.1097/MD.0000000000025426.
Reference Type
BACKGROUND
Varni JW, Bendo CB, Denham J, Shulman RJ, Self MM, Neigut DA, Nurko S, Patel AS, Franciosi JP, Saps M, Yeckes A, Langseder A, Saeed S, Pohl JF. PedsQL Gastrointestinal Symptoms Scales and Gastrointestinal Worry Scales in pediatric patients with functional and organic gastrointestinal diseases in comparison to healthy controls. Qual Life Res. 2015 Feb;24(2):363-78. doi: 10.1007/s11136-014-0781-x. Epub 2014 Aug 23.
Reference Type
BACKGROUND
Varni JW, Bendo CB, Nurko S, Shulman RJ, Self MM, Franciosi JP, Saps M, Pohl JF; Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Module Testing Study Consortium. Health-related quality of life in pediatric patients with functional and organic gastrointestinal diseases. J Pediatr. 2015 Jan;166(1):85-90. doi: 10.1016/j.jpeds.2014.08.022. Epub 2014 Sep 17.
Reference Type
BACKGROUND
Carlson MJ, Moore CE, Tsai CM, Shulman RJ, Chumpitazi BP. Child and parent perceived food-induced gastrointestinal symptoms and quality of life in children with functional gastrointestinal disorders. J Acad Nutr Diet. 2014 Mar;114(3):403-413. doi: 10.1016/j.jand.2013.10.013. Epub 2013 Dec 19.
Reference Type
BACKGROUND
Shava U, Srivastava A, Mathias A, Kumar N, Yachha SK, Gambhir S, Poddar U. Functional dyspepsia in children: A study of pathophysiological factors. J Gastroenterol Hepatol. 2021 Mar;36(3):680-686. doi: 10.1111/jgh.15193. Epub 2020 Aug 5.
Reference Type
BACKGROUND
Waseem S, Rubin L. A comprehensive review of functional dyspepsia in pediatrics. Clin J Gastroenterol. 2022 Feb;15(1):30-40. doi: 10.1007/s12328-021-01561-w. Epub 2021 Dec 2.
Reference Type
BACKGROUND
Pasricha PJ, Yates KP, Nguyen L, Clarke J, Abell TL, Farrugia G, Hasler WL, Koch KL, Snape WJ, McCallum RW, Sarosiek I, Tonascia J, Miriel LA, Lee L, Hamilton F, Parkman HP. Outcomes and Factors Associated With Reduced Symptoms in Patients With Gastroparesis. Gastroenterology. 2015 Dec;149(7):1762-1774.e4. doi: 10.1053/j.gastro.2015.08.008. Epub 2015 Aug 21.
Reference Type
BACKGROUND
Soykan I, Sivri B, Sarosiek I, Kiernan B, McCallum RW. Demography, clinical characteristics, psychological and abuse profiles, treatment, and long-term follow-up of patients with gastroparesis. Dig Dis Sci. 1998 Nov;43(11):2398-404. doi: 10.1023/a:1026665728213.
Reference Type
BACKGROUND
Grover M, Dasari S, Bernard CE, Chikkamenahalli LL, Yates KP, Pasricha PJ, Sarosiek I, McCallum R, Koch KL, Abell TL, Kuo B, Shulman RJ, Gibbons SJ, McKenzie TJ, Kellogg TA, Kendrick ML, Tonascia J, Hamilton FA, Parkman HP, Farrugia G. Proteomics in gastroparesis: unique and overlapping protein signatures in diabetic and idiopathic gastroparesis. Am J Physiol Gastrointest Liver Physiol. 2019 Nov 1;317(5):G716-G726. doi: 10.1152/ajpgi.00115.2019. Epub 2019 Sep 4.
Reference Type
BACKGROUND
Grover M, Gibbons SJ, Nair AA, Bernard CE, Zubair AS, Eisenman ST, Wilson LA, Miriel L, Pasricha PJ, Parkman HP, Sarosiek I, McCallum RW, Koch KL, Abell TL, Snape WJ, Kuo B, Shulman RJ, McKenzie TJ, Kellogg TA, Kendrick ML, Tonascia J, Hamilton FA, Farrugia G; NIDDK Gastroparesis Clinical Research Consortium (GpCRC). Transcriptomic signatures reveal immune dysregulation in human diabetic and idiopathic gastroparesis. BMC Med Genomics. 2018 Aug 7;11(1):62. doi: 10.1186/s12920-018-0379-1.
Reference Type
BACKGROUND
Grover M, Bernard CE, Pasricha PJ, Lurken MS, Faussone-Pellegrini MS, Smyrk TC, Parkman HP, Abell TL, Snape WJ, Hasler WL, McCallum RW, Nguyen L, Koch KL, Calles J, Lee L, Tonascia J, Unalp-Arida A, Hamilton FA, Farrugia G; NIDDK Gastroparesis Clinical Research Consortium (GpCRC). Clinical-histological associations in gastroparesis: results from the Gastroparesis Clinical Research Consortium. Neurogastroenterol Motil. 2012 Jun;24(6):531-9, e249. doi: 10.1111/j.1365-2982.2012.01894.x. Epub 2012 Feb 17.
Reference Type
BACKGROUND
Grover M, Farrugia G, Lurken MS, Bernard CE, Faussone-Pellegrini MS, Smyrk TC, Parkman HP, Abell TL, Snape WJ, Hasler WL, Unalp-Arida A, Nguyen L, Koch KL, Calles J, Lee L, Tonascia J, Hamilton FA, Pasricha PJ; NIDDK Gastroparesis Clinical Research Consortium. Cellular changes in diabetic and idiopathic gastroparesis. Gastroenterology. 2011 May;140(5):1575-85.e8. doi: 10.1053/j.gastro.2011.01.046. Epub 2011 Feb 4.
Reference Type
BACKGROUND
Friesen CA, Lin Z, Singh M, Singh V, Schurman JV, Burchell N, Cocjin JT, McCallum RW. Antral inflammatory cells, gastric emptying, and electrogastrography in pediatric functional dyspepsia. Dig Dis Sci. 2008 Oct;53(10):2634-40. doi: 10.1007/s10620-008-0207-0. Epub 2008 Mar 5.
Reference Type
BACKGROUND
Schurman JV, Singh M, Singh V, Neilan N, Friesen CA. Symptoms and subtypes in pediatric functional dyspepsia: relation to mucosal inflammation and psychological functioning. J Pediatr Gastroenterol Nutr. 2010 Sep;51(3):298-303. doi: 10.1097/MPG.0b013e3181d1363c.
Reference Type
BACKGROUND
Singh V, Singh M, Schurman JV, Friesen CA. Histopathological changes in the gastroduodenal mucosa of children with functional dyspepsia. Pathol Res Pract. 2018 Aug;214(8):1173-1178. doi: 10.1016/j.prp.2018.06.014. Epub 2018 Jun 28.
Reference Type
BACKGROUND
Friesen C, Singh M, Singh V, Schurman JV. An observational study of headaches in children and adolescents with functional abdominal pain: Relationship to mucosal inflammation and gastrointestinal and somatic symptoms. Medicine (Baltimore). 2018 Jul;97(30):e11395. doi: 10.1097/MD.0000000000011395.
Reference Type
BACKGROUND
Taki M, Oshima T, Li M, Sei H, Tozawa K, Tomita T, Fukui H, Watari J, Miwa H. Duodenal low-grade inflammation and expression of tight junction proteins in functional dyspepsia. Neurogastroenterol Motil. 2019 Oct;31(10):e13576. doi: 10.1111/nmo.13576. Epub 2019 Feb 20.
Reference Type
BACKGROUND
Komori K, Ihara E, Minoda Y, Ogino H, Sasaki T, Fujiwara M, Oda Y, Ogawa Y. The Altered Mucosal Barrier Function in the Duodenum Plays a Role in the Pathogenesis of Functional Dyspepsia. Dig Dis Sci. 2019 Nov;64(11):3228-3239. doi: 10.1007/s10620-019-5470-8. Epub 2019 Jan 23.
Reference Type
BACKGROUND
Vanheel H, Vicario M, Vanuytsel T, Van Oudenhove L, Martinez C, Keita AV, Pardon N, Santos J, Soderholm JD, Tack J, Farre R. Impaired duodenal mucosal integrity and low-grade inflammation in functional dyspepsia. Gut. 2014 Feb;63(2):262-71. doi: 10.1136/gutjnl-2012-303857. Epub 2013 Mar 8.
Reference Type
BACKGROUND
Neilan NA, Garg UC, Schurman JV, Friesen CA. Intestinal permeability in children/adolescents with functional dyspepsia. BMC Res Notes. 2014 May 1;7:275. doi: 10.1186/1756-0500-7-275.
Reference Type
BACKGROUND
McOmber ME, Ou CN, Shulman RJ. Effects of timing, sex, and age on site-specific gastrointestinal permeability testing in children and adults. J Pediatr Gastroenterol Nutr. 2010 Mar;50(3):269-75. doi: 10.1097/MPG.0b013e3181aa3aa9.
Reference Type
BACKGROUND
Teshima CW, Meddings JB. The measurement and clinical significance of intestinal permeability. Curr Gastroenterol Rep. 2008 Oct;10(5):443-9. doi: 10.1007/s11894-008-0083-y.
Reference Type
BACKGROUND
Meddings JB, Gibbons I. Discrimination of site-specific alterations in gastrointestinal permeability in the rat. Gastroenterology. 1998 Jan;114(1):83-92. doi: 10.1016/s0016-5085(98)70636-5.
Reference Type
BACKGROUND
Abell TL, Camilleri M, Donohoe K, Hasler WL, Lin HC, Maurer AH, McCallum RW, Nowak T, Nusynowitz ML, Parkman HP, Shreve P, Szarka LA, Snape WJ Jr, Ziessman HA; American Neurogastroenterology and Motility Society and the Society of Nuclear Medicine. Consensus recommendations for gastric emptying scintigraphy: a joint report of the American Neurogastroenterology and Motility Society and the Society of Nuclear Medicine. Am J Gastroenterol. 2008 Mar;103(3):753-63. doi: 10.1111/j.1572-0241.2007.01636.x. Epub 2007 Nov 19.
Reference Type
BACKGROUND
Orthey P, Dadparvar S, Parkman HP, Maurer AH. Enhanced Gastric Emptying Scintigraphy to Assess Fundic Accommodation Using Intragastric Meal Distribution and Antral Contractility. J Nucl Med Technol. 2019 Jun;47(2):138-143. doi: 10.2967/jnmt.118.215566. Epub 2018 Aug 23.
Reference Type
BACKGROUND
Orthey P, Yu D, Van Natta ML, Ramsey FV, Diaz JR, Bennett PA, Iagaru AH, Fragomeni RS, McCallum RW, Sarosiek I, Hasler WL, Farrugia G, Grover M, Koch KL, Nguyen L, Snape WJ, Abell TL, Pasricha PJ, Tonascia J, Hamilton F, Parkman HP, Maurer AH; NIH Gastroparesis Consortium. Intragastric Meal Distribution During Gastric Emptying Scintigraphy for Assessment of Fundic Accommodation: Correlation with Symptoms of Gastroparesis. J Nucl Med. 2018 Apr;59(4):691-697. doi: 10.2967/jnumed.117.197053. Epub 2017 Sep 28.
Reference Type
BACKGROUND
Piessevaux H, Tack J, Walrand S, Pauwels S, Geubel A. Intragastric distribution of a standardized meal in health and functional dyspepsia: correlation with specific symptoms. Neurogastroenterol Motil. 2003 Oct;15(5):447-55. doi: 10.1046/j.1365-2982.2003.00431.x.
Reference Type
BACKGROUND
Wong GK, Shulman RJ, Chiou EH, Chumpitazi BP. Decreased relative diagnostic yield of esophagogastroduodenoscopy in children with gastroparesis. J Clin Gastroenterol. 2014 Mar;48(3):231-5. doi: 10.1097/MCG.0b013e318299c8dd.
Reference Type
BACKGROUND
Varni JW, Bendo CB, Denham J, Shulman RJ, Self MM, Neigut DA, Nurko S, Patel AS, Franciosi JP, Saps M, Verga B, Smith A, Yeckes A, Heinz N, Langseder A, Saeed S, Zacur GM, Pohl JF. PedsQL gastrointestinal symptoms module: feasibility, reliability, and validity. J Pediatr Gastroenterol Nutr. 2014 Sep;59(3):347-55. doi: 10.1097/MPG.0000000000000414.
Reference Type
BACKGROUND
Velasco-Benitez CA, Gomez-Oliveros LF, Rubio-Molina LM, Tovar-Cuevas JR, Saps M. Diagnostic Accuracy of the Rome IV Criteria for the Diagnosis of Functional Gastrointestinal Disorders in Children. J Pediatr Gastroenterol Nutr. 2021 Apr 1;72(4):538-541. doi: 10.1097/MPG.0000000000003030.
Reference Type
BACKGROUND
Sood MR, Schwankovsky LM, Rowhani A, Zangen T, Ziring D, Furtado T, Hyman PE. Water load test in children. J Pediatr Gastroenterol Nutr. 2002 Aug;35(2):199-201. doi: 10.1097/00005176-200208000-00017.
Reference Type
BACKGROUND
Walker LS, Williams SE, Smith CA, Garber J, Van Slyke DA, Lipani T, Greene JW, Mertz H, Naliboff BD. Validation of a symptom provocation test for laboratory studies of abdominal pain and discomfort in children and adolescents. J Pediatr Psychol. 2006 Aug;31(7):703-13. doi: 10.1093/jpepsy/jsj062. Epub 2006 Jul 20.
Reference Type
BACKGROUND
Thomson H, Francis DM. Abdominal-wall tenderness: A useful sign in the acute abdomen. Lancet. 1977 Nov 19;2(8047):1053-4. doi: 10.1016/s0140-6736(77)91885-2.
Reference Type
BACKGROUND
Carbone F, Fikree A, Aziz Q, Tack J. Joint Hypermobility Syndrome in Patients With Functional Dyspepsia. Clin Transl Gastroenterol. 2020 Nov;11(11):e00220. doi: 10.14309/ctg.0000000000000220.
Reference Type
BACKGROUND
Beighton P, Solomon L, Soskolne CL. Articular mobility in an African population. Ann Rheum Dis. 1973 Sep;32(5):413-8. doi: 10.1136/ard.32.5.413. No abstract available.
Reference Type
BACKGROUND
Smits-Engelsman B, Klerks M, Kirby A. Beighton score: a valid measure for generalized hypermobility in children. J Pediatr. 2011 Jan;158(1):119-23, 123.e1-4. doi: 10.1016/j.jpeds.2010.07.021. Epub 2010 Sep 17.
Reference Type
BACKGROUND
Chelimsky G, Kovacic K, Simpson P, Nugent M, Basel D, Banda J, Chelimsky T. Benign Joint Hypermobility Minimally Impacts Autonomic Abnormalities in Pediatric Subjects with Chronic Functional Pain Disorders. J Pediatr. 2016 Oct;177:49-52. doi: 10.1016/j.jpeds.2016.06.091. Epub 2016 Aug 2.
Reference Type
BACKGROUND
Kovacic K, Chelimsky TC, Sood MR, Simpson P, Nugent M, Chelimsky G. Joint hypermobility: a common association with complex functional gastrointestinal disorders. J Pediatr. 2014 Nov;165(5):973-8. doi: 10.1016/j.jpeds.2014.07.021. Epub 2014 Aug 20.
Reference Type
BACKGROUND
Juul-Kristensen B, Schmedling K, Rombaut L, Lund H, Engelbert RH. Measurement properties of clinical assessment methods for classifying generalized joint hypermobility-A systematic review. Am J Med Genet C Semin Med Genet. 2017 Mar;175(1):116-147. doi: 10.1002/ajmg.c.31540.
Reference Type
BACKGROUND
Remvig L, Flycht L, Christensen KB, Juul-Kristensen B. Lack of consensus on tests and criteria for generalized joint hypermobility, Ehlers-Danlos syndrome: hypermobile type and joint hypermobility syndrome. Am J Med Genet A. 2014 Mar;164A(3):591-6. doi: 10.1002/ajmg.a.36402. Epub 2014 Jan 24.
Reference Type
BACKGROUND
Shulman RJ, Self MM, Czyzewski DI, Goldberg J, Heitkemper M. The Prevalence of Hypermobility in Children with Irritable Bowel Syndrome and Functional Abdominal Pain Is Similar to that in Healthy Children. J Pediatr. 2020 Jul;222:134-140.e2. doi: 10.1016/j.jpeds.2020.03.033. Epub 2020 May 4.
Reference Type
BACKGROUND
Vera JF, Gotteland M, Chavez E, Vial MT, Kakarieka E, Brunser O. Sucrose permeability in children with gastric damage and Helicobacter pylori infection. J Pediatr Gastroenterol Nutr. 1997 May;24(5):506-11. doi: 10.1097/00005176-199705000-00002.
Reference Type
BACKGROUND
Sutherland LR, Verhoef M, Wallace JL, Van Rosendaal G, Crutcher R, Meddings JB. A simple, non-invasive marker of gastric damage: sucrose permeability. Lancet. 1994 Apr 23;343(8904):998-1000. doi: 10.1016/s0140-6736(94)90125-2.
Reference Type
BACKGROUND
Catassi C, Pierani P, Natalini G, Gabrielli O, Coppa GV, Giorgi PL. Clinical application of a simple HPLC method for the sugar intestinal permeability test. J Pediatr Gastroenterol Nutr. 1991 Feb;12(2):209-12. doi: 10.1097/00005176-199102000-00012.
Reference Type
BACKGROUND
Meddings JB, Sutherland LR, Byles NI, Wallace JL. Sucrose: a novel permeability marker for gastroduodenal disease. Gastroenterology. 1993 Jun;104(6):1619-26. doi: 10.1016/0016-5085(93)90637-r.
Reference Type
BACKGROUND
Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.
Reference Type
BACKGROUND
Febo-Rodriguez L, Chumpitazi BP, Musaad S, Sher AC, Varni JW, Shulman RJ. Gastrointestinal Symptoms Profile in Pediatric Patients With Gastroparesis Compared to Healthy Controls. J Pediatr Gastroenterol Nutr. 2022 Aug 1;75(2):151-158. doi: 10.1097/MPG.0000000000003484. Epub 2022 Jun 1.
Reference Type
BACKGROUND
Walker LS, Beck JE, Garber J, Lambert W. Children's Somatization Inventory: psychometric properties of the revised form (CSI-24). J Pediatr Psychol. 2009 May;34(4):430-40. doi: 10.1093/jpepsy/jsn093. Epub 2008 Sep 9.
Reference Type
BACKGROUND
Knight D, Hensley VR, Waters B. Validation of the Children's Depression Scale and the Children's Depression Inventory in a prepubertal sample. J Child Psychol Psychiatry. 1988 Nov;29(6):853-63. doi: 10.1111/j.1469-7610.1988.tb00758.x.
Reference Type
BACKGROUND
Claar RL, Walker LS. Functional assessment of pediatric pain patients: psychometric properties of the functional disability inventory. Pain. 2006 Mar;121(1-2):77-84. doi: 10.1016/j.pain.2005.12.002. Epub 2006 Feb 9.
Reference Type
BACKGROUND
Pielech M, Ryan M, Logan D, Kaczynski K, White MT, Simons LE. Pain catastrophizing in children with chronic pain and their parents: proposed clinical reference points and reexamination of the Pain Catastrophizing Scale measure. Pain. 2014 Nov;155(11):2360-7. doi: 10.1016/j.pain.2014.08.035. Epub 2014 Aug 29.
Reference Type
BACKGROUND
Wytiaz V, Homko C, Duffy F, Schey R, Parkman HP. Foods provoking and alleviating symptoms in gastroparesis: patient experiences. Dig Dis Sci. 2015 Apr;60(4):1052-8. doi: 10.1007/s10620-015-3651-7. Epub 2015 Apr 4.
Reference Type
BACKGROUND
Pilichiewicz AN, Horowitz M, Holtmann GJ, Talley NJ, Feinle-Bisset C. Relationship between symptoms and dietary patterns in patients with functional dyspepsia. Clin Gastroenterol Hepatol. 2009 Mar;7(3):317-22. doi: 10.1016/j.cgh.2008.09.007. Epub 2008 Sep 20.
Reference Type
BACKGROUND
Rockett HR, Breitenbach M, Frazier AL, Witschi J, Wolf AM, Field AE, Colditz GA. Validation of a youth/adolescent food frequency questionnaire. Prev Med. 1997 Nov-Dec;26(6):808-16. doi: 10.1006/pmed.1997.0200.
Reference Type
BACKGROUND
Chumpitazi BP, Weidler EM, Lu DY, Tsai CM, Shulman RJ. Self-Perceived Food Intolerances Are Common and Associated with Clinical Severity in Childhood Irritable Bowel Syndrome. J Acad Nutr Diet. 2016 Sep;116(9):1458-1464. doi: 10.1016/j.jand.2016.04.017. Epub 2016 Jun 15.
Reference Type
BACKGROUND
Revicki DA, Camilleri M, Kuo B, Szarka LA, McCormack J, Parkman HP. Evaluating symptom outcomes in gastroparesis clinical trials: validity and responsiveness of the Gastroparesis Cardinal Symptom Index-Daily Diary (GCSI-DD). Neurogastroenterol Motil. 2012 May;24(5):456-63, e215-6. doi: 10.1111/j.1365-2982.2012.01879.x. Epub 2012 Jan 27.
Reference Type
BACKGROUND
Parkman HP, Camilleri M, Farrugia G, McCallum RW, Bharucha AE, Mayer EA, Tack JF, Spiller R, Horowitz M, Vinik AI, Galligan JJ, Pasricha PJ, Kuo B, Szarka LA, Marciani L, Jones K, Parrish CR, Sandroni P, Abell T, Ordog T, Hasler W, Koch KL, Sanders K, Norton NJ, Hamilton F. Gastroparesis and functional dyspepsia: excerpts from the AGA/ANMS meeting. Neurogastroenterol Motil. 2010 Feb;22(2):113-33. doi: 10.1111/j.1365-2982.2009.01434.x. Epub 2009 Dec 9.
Reference Type
BACKGROUND
Pasricha PJ, Camilleri M, Hasler WL, Parkman HP. White Paper AGA: Gastroparesis: Clinical and Regulatory Insights for Clinical Trials. Clin Gastroenterol Hepatol. 2017 Aug;15(8):1184-1190. doi: 10.1016/j.cgh.2017.04.011. Epub 2017 Apr 12.
Reference Type
BACKGROUND
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
Reference Type
BACKGROUND
Grahame R, Bird HA, Child A. The revised (Brighton 1998) criteria for the diagnosis of benign joint hypermobility syndrome (BJHS). J Rheumatol. 2000 Jul;27(7):1777-9. No abstract available.
Reference Type
BACKGROUND
Tougas G, Eaker EY, Abell TL, Abrahamsson H, Boivin M, Chen J, Hocking MP, Quigley EM, Koch KL, Tokayer AZ, Stanghellini V, Chen Y, Huizinga JD, Ryden J, Bourgeois I, McCallum RW. Assessment of gastric emptying using a low fat meal: establishment of international control values. Am J Gastroenterol. 2000 Jun;95(6):1456-62. doi: 10.1111/j.1572-0241.2000.02076.x.
Reference Type
BACKGROUND
Baxter AL, Watcha MF, Baxter WV, Leong T, Wyatt MM. Development and validation of a pictorial nausea rating scale for children. Pediatrics. 2011 Jun;127(6):e1542-9. doi: 10.1542/peds.2010-1410. Epub 2011 May 29.
Reference Type
BACKGROUND
Varni JW, Burwinkle TM, Seid M, Skarr D. The PedsQL 4.0 as a pediatric population health measure: feasibility, reliability, and validity. Ambul Pediatr. 2003 Nov-Dec;3(6):329-41. doi: 10.1367/1539-4409(2003)0032.0.co;2.
Reference Type
BACKGROUND
Walker LS, Garber J, Greene JW. Psychosocial correlates of recurrent childhood pain: a comparison of pediatric patients with recurrent abdominal pain, organic illness, and psychiatric disorders. J Abnorm Psychol. 1993 May;102(2):248-58. doi: 10.1037//0021-843x.102.2.248.
Reference Type
BACKGROUND
Kovacs M. Rating scales to assess depression in school-aged children. Acta Paedopsychiatr. 1981 Feb;46(5-6):305-15. No abstract available.
Reference Type
BACKGROUND
Walker LS, Greene JW. The functional disability inventory: measuring a neglected dimension of child health status. J Pediatr Psychol. 1991 Feb;16(1):39-58. doi: 10.1093/jpepsy/16.1.39.
Reference Type
BACKGROUND
Parkerson HA, Noel M, Page MG, Fuss S, Katz J, Asmundson GJ. Factorial validity of the English-language version of the Pain Catastrophizing Scale--child version. J Pain. 2013 Nov;14(11):1383-9. doi: 10.1016/j.jpain.2013.06.004. Epub 2013 Sep 5.
Reference Type
BACKGROUND
Simren M, Mansson A, Langkilde AM, Svedlund J, Abrahamsson H, Bengtsson U, Bjornsson ES. Food-related gastrointestinal symptoms in the irritable bowel syndrome. Digestion. 2001;63(2):108-15. doi: 10.1159/000051878.
Reference Type
BACKGROUND
Tringali A, Balassone V, De Angelis P, Landi R. Complications in pediatric endoscopy. Best Pract Res Clin Gastroenterol. 2016 Oct;30(5):825-839. doi: 10.1016/j.bpg.2016.09.006. Epub 2016 Sep 13.
Reference Type
BACKGROUND
Walker LS, Caplan-Dover A, Rasquin-Weber A. Manual for the Questionnaire on Pediatric Gastrointestinal Disorders. Nashville: Vanderbilt University School of Medicine, 2000.
Reference Type
BACKGROUND
Spielberger CD. Manual for the State-Trait Anxiety Inventory for Children. Palo Alto: Consulting Psychologists Press, 1973.
Reference Type
BACKGROUND
PASS 2023 Power Analysis and Sample Size Software (2023). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB00416909
Identifier Type: OTHER
Identifier Source: secondary_id
15-DK-PGpR2
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
The Rett Syndrome Global Registry
NCT04900493
RECRUITING
Multisite Feeding Study: Home Surveillance and Feeding Strategies in Infants With Complex Single Ventricle
NCT00257517
COMPLETED
Endoscopic Ultrasound Findings in Esophageal Atresia Following Surgical Repair
NCT04259528
UNKNOWN
NA
An Enhanced Medical Home for High-Risk Chronically Ill Children
NCT02128776
COMPLETED
NA
EEG Characteristics in Youth POTS and/or Syncope
NCT02167412
COMPLETED
Gastric Ultrasound to Monitor Gastric Residual Volume
NCT04119089
COMPLETED
Gastric Content Ultrasound Monitoring Prior to Extubation in Critically Ill Children
NCT05181904
TERMINATED
Prospective Evaluation of Blunt Renal Injury in Children
NCT00855036
TERMINATED
HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants
NCT04177914
RECRUITING
PHASE3
Non-invasive Intracranial Pressure (ICP) Monitoring in Pediatric Patients
NCT02695264
WITHDRAWN
NA
Multicenter Prospective Cohort Study on Current Treatments of Legg-Calvé-Perthes Disease
NCT02040714
ENROLLING_BY_INVITATION
ROLE OF PELVIC ULTRASOUND IN THE TREATMENT MONITORING OF CHILDREN WITH CHRONIC Idiopathic Constipation
NCT05787093
UNKNOWN
Bladder Neck Surgery in Children With Neurogenic Bladder
NCT05861011
COMPLETED
Multi-omics Research of Idopathic Normal Pressure Hydrocephalus (iNPH)
NCT04998175
UNKNOWN
NA
A Prospective Evaluation of Non-Operative Treatments for Gastrocutaneous Fistulae in Children
NCT03920306
UNKNOWN
PHASE4
Fetal Endotracheal Occlusion (FETO) in Severe and Extremely Severe Congenital Diaphragmatic Hernia
NCT00881660
COMPLETED
NA
Enema Device for Children With Spina Bifida
NCT05253196
NOT_YET_RECRUITING
NA
The U.S. PDA Registry
NCT04205877
NOT_YET_RECRUITING
Improving Infant Hydrocephalus Outcomes in Uganda
NCT03650101
RECRUITING
Comparison of Stent-Related Symptoms Between Anti-Reflux Stents and Standard DJ Stents in Children With Urolithiasis
NCT06569173
RECRUITING
NA
Pediatric Teduglutide Registry
NCT04832087
COMPLETED
Evaluation of the Efficiency of Autologous Adipocytes Graft in Endoscopic Treatment in Vesico-Renal Reflux in Children
NCT00367159
UNKNOWN
PHASE3
Optimal Positioning of Nasopharyngeal Temperature Probes
NCT02993003
WITHDRAWN
NA
Pediatric Percutaneous Ultrasound Gastrostomy Technique
NCT05966311
RECRUITING
NA