Clinical trial NCT05846802: Gastroparesis Registry 4
Official title: Gastroparesis Registry 4 (GpR4): Improving the Understanding of Gastroparesis and Functional Dyspepsia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastroparesis
Gastroparesis Nondiabetic
Gastroparesis Due to Diabetes Mellitus Type I
Gastroparesis Due to Diabetes Mellitus Type II
Functional Disorder of Gastrointestinal Tract
Gastro-Intestinal Disorder
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Texas Tech University Health Sciences Center, El Paso
name: Temple University
name: University of Louisville
name: Mayo Clinic
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Massachusetts General Hospital
name: Wake Forest University
First posted: 2023-05-06
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults over age 18, located in the United States, with symptoms of gastroparesis and/or functional dyspepsia.

Brief summary: The Gastroparesis Registry 4 (GpR4) is an observational study of patients with symptoms of gastroparesis (Gp) and functional dyspepsia (FD) 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 patients and their clinical course. Participants will complete several questionnaires, complete a nutrient drink test and have a gastric emptying study.

Detailed description: This observational study of patients with symptoms of gastroparesis (Gp) and functional dyspepsia (FD) with either delayed or normal gastric emptying aims to assess the clinical, pathophysiological, and psychological similarities and differences between patients with Gp, FD.

The primary outcome will be the measure of symptom severity of gastroparesis and functional dyspepsia using the change in total score from the Patient Assessment of Upper Gastrointestinal Disorders Symptoms (PAGI SYM) from baseline to 48 weeks.

Eligibility criteria: Inclusion Criteria:

* Age at least 18 years at initial screening visit
* Symptoms of Gp and/or FD of at least 12-weeks duration with varying degrees of nausea, vomiting, early satiety, postprandial fullness, abdominal pain, abdominal burning. Thus, patients can enter the GpR4 registry primarily with abdominal pain suggesting FD-Epigastric Pain Syndrome.
* Successful completion of gastric emptying scintigraphy of solids using the 4-hour Egg Beaters® protocol (or equivalent generic liquid egg white meal) within the last 6 months
* Negative upper endoscopy or upper radiographic GI series within 2 years of registration

Exclusion Criteria:

* Use of narcotic analgesics greater than three days per week
* Presence of other conditions that could explain the patient's symptoms such as:
* Pyloric or intestinal obstruction as evidenced by EGD, UGI, or Abdominal CT
* Active inflammatory bowel disease
* Known eosinophilic gastroenteritis or eosinophilic esophagitis
* Primary neurological conditions that can cause nausea and vomiting such as increased intracranial pressure, space occupying or inflammatory/infectious lesions
* Acute or chronic renal failure (serum creatinine \>3 mg/dL) and/or on hemodialysis or peritoneal dialysis
* Acute liver failure or advanced liver disease (Child's B or C; a Child-Pugh-Turcotte (CPT) score of ≥7)
* Pancreatic disorder if present on pancreatic imaging or pancreatic function testing
* Prior gastric surgery including total or subtotal (near complete) gastric resection, esophagectomy, gastrojejunostomy, gastric bypass, gastric sleeve, pyloroplasty, pyloromyotomy, or any fundoplication (Nissen, Tor)
* Any other condition, which in the opinion of the investigator, could explain the symptoms or interfere with study requirements
* Females who are pregnant. A urine pregnancy test is routinely obtained on all females immediately prior to gastric emptying procedures.
* Inability to comply with or complete the gastric emptying scintigraphy test (including allergy to eggs)
* Inability to obtain informed consent

Primary outcomes:
measure: Measure of symptom severity of gastroparesis and functional dyspepsia using the change in total score from the Patient Assessment of Upper Gastrointestinal Disorders Symptoms (PAGI SYM) from baseline to 48 weeks.
timeFrame: 48 weeks
Secondary outcomes:
measure: Changes in gastric emptying, as measured by gastric emptying scintigraphy (GES) at baseline and 48 weeks
timeFrame: Baseline, 48 weeks
Other outcomes:
measure: Presence or absence of Carnett's sign for abdominal wall pain at baseline.
timeFrame: Baseline
Locations:
city: Scottsdale
country: United States
facility: Jay Pasricha
state: Arizona
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Charlotte
country: United States
facility: Wake Forest University and Atrium Health Carolinas Medical Center
state: North Carolina
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: El Paso
country: United States
facility: Texas Tech University Health Science Center (TTUHSC)
state: Texas
Study officials:
affiliation: Mayo Clinic
name: Jay Pasricha, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Temple University
name: Henry Parkman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins Bloomberg School of Public Health
name: David Shade, JD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parkman HP, Hasler WL, Fisher RS; American Gastroenterological Association. American Gastroenterological Association technical review on the diagnosis and treatment of gastroparesis. Gastroenterology. 2004 Nov;127(5):1592-622. doi: 10.1053/j.gastro.2004.09.055.
citation: 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.
citation: Stanghellini V, Chan FK, Hasler WL, Malagelada JR, Suzuki H, Tack J, Talley NJ. Gastroduodenal Disorders. Gastroenterology. 2016 May;150(6):1380-92. doi: 10.1053/j.gastro.2016.02.011.
citation: Schol J, Wauters L, Dickman R, Drug V, Mulak A, Serra J, Enck P, Tack J; ESNM Gastroparesis Consensus Group. United European Gastroenterology (UEG) and European Society for Neurogastroenterology and Motility (ESNM) consensus on gastroparesis. Neurogastroenterol Motil. 2021 Aug;33(8):e14237. doi: 10.1111/nmo.14237.
citation: 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.
citation: Pasricha PJ, Colvin R, Yates K, Hasler WL, Abell TL, Unalp-Arida A, Nguyen L, Farrugia G, Koch KL, Parkman HP, Snape WJ, Lee L, Tonascia J, Hamilton F. Characteristics of patients with chronic unexplained nausea and vomiting and normal gastric emptying. Clin Gastroenterol Hepatol. 2011 Jul;9(7):567-76.e1-4. doi: 10.1016/j.cgh.2011.03.003. Epub 2011 Mar 11.
citation: Makarov OV, Khashchukoeva AZ, Borisenko SA, Epeikina TN, Moiseeva NB. [Immunologic aspects of ovarian tumors]. Akush Ginekol (Mosk). 1988 Nov;(11):3-6. No abstract available. Russian.
citation: 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.
citation: Lacy BE, Crowell MD, Cangemi DJ, Lunsford TN, Simren M, Tack J. Diagnostic Evaluation of Gastric Motor and Sensory Disorders. Am J Gastroenterol. 2021 Dec 1;116(12):2345-2356. doi: 10.14309/ajg.0000000000001562.
citation: Revicki DA, Camilleri M, Kuo B, Norton NJ, Murray L, Palsgrove A, Parkman HP. Development and content validity of a gastroparesis cardinal symptom index daily diary. Aliment Pharmacol Ther. 2009 Sep 15;30(6):670-80. doi: 10.1111/j.1365-2036.2009.04078.x. Epub 2009 Jun 25.
citation: Yu D, Ramsey FV, Norton WF, Norton N, Schneck S, Gaetano T, Parkman HP. The Burdens, Concerns, and Quality of Life of Patients with Gastroparesis. Dig Dis Sci. 2017 Apr;62(4):879-893. doi: 10.1007/s10620-017-4456-7. Epub 2017 Jan 21.
citation: Parkman HP, Wilson LA, Yates KP, Koch KL, Abell TL, McCallum RW, Sarosiek I, Kuo B, Malik Z, Schey R, Shulman RJ, Grover M, Farrugia G, Miriel L, Tonascia J, Hamilton F, Pasricha PJ; NIDDK/NIH Clinical Gastroparesis Consortium. Factors that contribute to the impairment of quality of life in gastroparesis. Neurogastroenterol Motil. 2021 Aug;33(8):e14087. doi: 10.1111/nmo.14087. Epub 2021 Jan 25.
citation: Hasler WL, Wilson LA, Parkman HP, Koch KL, Abell TL, Nguyen L, Pasricha PJ, Snape WJ, McCallum RW, Sarosiek I, Farrugia G, Calles J, Lee L, Tonascia J, Unalp-Arida A, Hamilton F. Factors related to abdominal pain in gastroparesis: contrast to patients with predominant nausea and vomiting. Neurogastroenterol Motil. 2013 May;25(5):427-38, e300-1. doi: 10.1111/nmo.12091. Epub 2013 Feb 17.
citation: Hasler WL, Wilson LA, Nguyen LA, Snape WJ, Abell TL, Koch KL, McCallum RW, Pasricha PJ, Sarosiek I, Farrugia G, Grover M, Lee LA, Miriel L, Tonascia J, Hamilton FA, Parkman HP; Gastroparesis Clinical Research Consortium. Opioid Use and Potency Are Associated With Clinical Features, Quality of Life, and Use of Resources in Patients With Gastroparesis. Clin Gastroenterol Hepatol. 2019 Jun;17(7):1285-1294.e1. doi: 10.1016/j.cgh.2018.10.013. Epub 2018 Oct 13.
citation: Parkman HP, Wilson LA, Hasler WL, McCallum RW, Sarosiek I, Koch KL, Abell TL, Schey R, Kuo B, Snape WJ, Nguyen L, Farrugia G, Grover M, Clarke J, Miriel L, Tonascia J, Hamilton F, Pasricha PJ. Abdominal Pain in Patients with Gastroparesis: Associations with Gastroparesis Symptoms, Etiology of Gastroparesis, Gastric Emptying, Somatization, and Quality of Life. Dig Dis Sci. 2019 Aug;64(8):2242-2255. doi: 10.1007/s10620-019-05522-9. Epub 2019 Mar 9.
citation: Glissen Brown JR, Bernstein GR, Friedenberg FK, Ehrlich AC. Chronic Abdominal Wall Pain: An Under-Recognized Diagnosis Leading to Unnecessary Testing. J Clin Gastroenterol. 2016 Nov/Dec;50(10):828-835. doi: 10.1097/MCG.0000000000000636.
citation: Camilleri M, Chedid V, Ford AC, Haruma K, Horowitz M, Jones KL, Low PA, Park SY, Parkman HP, Stanghellini V. Gastroparesis. Nat Rev Dis Primers. 2018 Nov 1;4(1):41. doi: 10.1038/s41572-018-0038-z.
citation: 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.
citation: Parkman HP, Yates K, Hasler WL, Nguyen L, Pasricha PJ, Snape WJ, Farrugia G, Koch KL, Calles J, 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. Similarities and differences between diabetic and idiopathic gastroparesis. Clin Gastroenterol Hepatol. 2011 Dec;9(12):1056-64; quiz e133-4. doi: 10.1016/j.cgh.2011.08.013. Epub 2011 Aug 24.
citation: 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.
citation: Gourcerol G, Melchior C, Wuestenberghs F, Desprez C, Prevost G, Grosjean J, Leroi AM, Tavolacci MP. Delayed gastric emptying as an independent predictor of mortality in gastroparesis. Aliment Pharmacol Ther. 2022 Apr;55(7):867-875. doi: 10.1111/apt.16827. Epub 2022 Feb 20.
citation: 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.
citation: Gaddipati KV, Simonian HP, Kresge KM, Boden GH, Parkman HP. Abnormal ghrelin and pancreatic polypeptide responses in gastroparesis. Dig Dis Sci. 2006 Aug;51(8):1339-46. doi: 10.1007/s10620-005-9022-z. Epub 2006 Jul 26.
citation: Nguyen L, Wilson LA, Miriel L, Pasricha PJ, Kuo B, Hasler WL, McCallum RW, Sarosiek I, Koch KL, Snape WJ, Farrugia G, Grover M, Clarke J, Parkman HP, Tonascia J, Hamilton F, Abell TL; NIDDK Gastroparesis Clinical Research Consortium (GpCRC). Autonomic function in gastroparesis and chronic unexplained nausea and vomiting: Relationship with etiology, gastric emptying, and symptom severity. Neurogastroenterol Motil. 2020 Aug;32(8):e13810. doi: 10.1111/nmo.13810. Epub 2020 Feb 15.
citation: 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.
citation: 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.
citation: Abell TL, Yamada G, McCallum RW, Van Natta ML, Tonascia J, Parkman HP, Koch KL, Sarosiek I, Farrugia G, Grover M, Hasler W, Nguyen L, Snape W, Kuo B, Shulman R, Hamilton FA, Pasricha PJ. Effectiveness of gastric electrical stimulation in gastroparesis: Results from a large prospectively collected database of national gastroparesis registries. Neurogastroenterol Motil. 2019 Dec;31(12):e13714. doi: 10.1111/nmo.13714. Epub 2019 Oct 4.
citation: Sarosiek I, Van Natta M, Parkman HP, Abell T, Koch KL, Kuo B, Shulman RJ, Farrugia G, Grover M, Hamilton FA, Pasricha PJ, Yates KP, Miriel L, Wilson L, Yamada G, Tonascia J, McCallum RW; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Gastroparesis Clinical Research Consortium (GpCRC). Effect of Domperidone Therapy on Gastroparesis Symptoms: Results of a Dynamic Cohort Study by NIDDK Gastroparesis Consortium. Clin Gastroenterol Hepatol. 2022 Mar;20(3):e452-e464. doi: 10.1016/j.cgh.2021.05.063. Epub 2021 Jun 2.
citation: Revicki DA, Rentz AM, Dubois D, Kahrilas P, Stanghellini V, Talley NJ, Tack J. Development and validation of a patient-assessed gastroparesis symptom severity measure: the Gastroparesis Cardinal Symptom Index. Aliment Pharmacol Ther. 2003 Jul 1;18(1):141-50. doi: 10.1046/j.1365-2036.2003.01612.x.
citation: Fraser A, Delaney BC, Ford AC, Qume M, Moayyedi P. The Short-Form Leeds Dyspepsia Questionnaire validation study. Aliment Pharmacol Ther. 2007 Feb 15;25(4):477-86. doi: 10.1111/j.1365-2036.2006.03233.x.
citation: 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.
citation: Scarpellini E, Van den Houte K, Schol J, Huang IH, Colomier E, Carbone F, Tack J. Nutrient Drinking Test as Biomarker in Functional Dyspepsia. Am J Gastroenterol. 2021 Jul 1;116(7):1387-1395. doi: 10.14309/ajg.0000000000001242.
citation: Koch KL, Hasler WL, Van Natta M, Calles-Escandon J, Grover M, Pasricha PJ, Snape WJ, Parkman HP, Abell TL, McCallum RW, Nguyen LA, Sarosiek I, Farrugia G, Tonascia J, Lee L, Miriel L, Hamilton F; NIDDK Gastroparesis Clinical Research Consortium. Satiety testing in diabetic gastroparesis: Effects of insulin pump therapy with continuous glucose monitoring on upper gastrointestinal symptoms and gastric myoelectrical activity. Neurogastroenterol Motil. 2020 Jan;32(1):e13720. doi: 10.1111/nmo.13720. Epub 2019 Oct 1.
citation: Parkman HP, Jones MP. Tests of gastric neuromuscular function. Gastroenterology. 2009 May;136(5):1526-43. doi: 10.1053/j.gastro.2009.02.039. Epub 2009 Mar 16.
citation: Chial HJ, Camilleri C, Delgado-Aros S, Burton D, Thomforde G, Ferber I, Camilleri M. A nutrient drink test to assess maximum tolerated volume and postprandial symptoms: effects of gender, body mass index and age in health. Neurogastroenterol Motil. 2002 Jun;14(3):249-53. doi: 10.1046/j.1365-2982.2002.00326.x.
citation: Delgado-Aros S, Cremonini F, Castillo JE, Chial HJ, Burton DD, Ferber I, Camilleri M. Independent influences of body mass and gastric volumes on satiation in humans. Gastroenterology. 2004 Feb;126(2):432-40. doi: 10.1053/j.gastro.2003.11.007.
citation: Mottalib A, Abrahamson MJ, Pober DM, Polak R, Eldib AH, Tomah S, Ashrafzadeh S, Hamdy O. Effect of diabetes-specific nutrition formulas on satiety and hunger hormones in patients with type 2 diabetes. Nutr Diabetes. 2019 Sep 24;9(1):26. doi: 10.1038/s41387-019-0093-x.
citation: Phillips AE, Faghih M, Kuhlmann L, Larsen IM, Drewes AM, Singh VK, Yadav D, Olesen SS; Pancreatic Quantitative Sensory Testing (P-QST) Consortium. A clinically feasible method for the assessment and characterization of pain in patients with chronic pancreatitis. Pancreatology. 2020 Jan;20(1):25-34. doi: 10.1016/j.pan.2019.11.007. Epub 2019 Nov 20.
citation: Sletten DM, Suarez GA, Low PA, Mandrekar J, Singer W. COMPASS 31: a refined and abbreviated Composite Autonomic Symptom Score. Mayo Clin Proc. 2012 Dec;87(12):1196-201. doi: 10.1016/j.mayocp.2012.10.013.
citation: Song J, Bhuta R, Baig K, Parkman HP, Malik Z. COVID-19 infection manifesting as a severe gastroparesis flare: A case report. Medicine (Baltimore). 2021 Apr 9;100(14):e25467. doi: 10.1097/MD.0000000000025467.
citation: Palsson OS, Whitehead WE, van Tilburg MA, Chang L, Chey W, Crowell MD, Keefer L, Lembo AJ, Parkman HP, Rao SS, Sperber A, Spiegel B, Tack J, Vanner S, Walker LS, Whorwell P, Yang Y. Rome IV Diagnostic Questionnaires and Tables for Investigators and Clinicians. Gastroenterology. 2016 Feb 13:S0016-5085(16)00180-3. doi: 10.1053/j.gastro.2016.02.014. Online ahead of print.
citation: Talley NJ, Verlinden M, Jones M. Quality of life in functional dyspepsia: responsiveness of the Nepean Dyspepsia Index and development of a new 10-item short form. Aliment Pharmacol Ther. 2001 Feb;15(2):207-16. doi: 10.1046/j.1365-2036.2001.00900.x.
citation: de la Loge C, Trudeau E, Marquis P, Kahrilas P, Stanghellini V, Talley NJ, Tack J, Revicki DA, Rentz AM, Dubois D. Cross-cultural development and validation of a patient self-administered questionnaire to assess quality of life in upper gastrointestinal disorders: the PAGI-QOL. Qual Life Res. 2004 Dec;13(10):1751-62. doi: 10.1007/s11136-004-8751-3.
citation: Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
citation: Kroenke K, Spitzer RL, Williams JB. The PHQ-15: validity of a new measure for evaluating the severity of somatic symptoms. Psychosom Med. 2002 Mar-Apr;64(2):258-66. doi: 10.1097/00006842-200203000-00008.
citation: Taylor F, Higgins S, Carson RT, Eremenco S, Foley C, Lacy BE, Parkman HP, Reasner DS, Shields AL, Tack J, Talley NJ; Patient-Reported Outcome Consortium's Functional Dyspepsia Working Group. Development of a Symptom-Focused Patient-Reported Outcome Measure for Functional Dyspepsia: The Functional Dyspepsia Symptom Diary (FDSD). Am J Gastroenterol. 2018 Jan;113(1):39-48. doi: 10.1038/ajg.2017.265. Epub 2017 Sep 19.
citation: Hasler WL, Parkman HP, Wilson LA, Pasricha PJ, Koch KL, Abell TL, Snape WJ, Farrugia G, Lee L, Tonascia J, Unalp-Arida A, Hamilton F; NIDDK Gastroparesis Clinical Research Consortium. Psychological dysfunction is associated with symptom severity but not disease etiology or degree of gastric retention in patients with gastroparesis. Am J Gastroenterol. 2010 Nov;105(11):2357-67. doi: 10.1038/ajg.2010.253. Epub 2010 Jun 29.
citation: DiBaise JK, Patel N, Noelting J, Dueck AC, Roarke M, Crowell MD. The relationship among gastroparetic symptoms, quality of life, and gastric emptying in patients referred for gastric emptying testing. Neurogastroenterol Motil. 2016 Feb;28(2):234-42. doi: 10.1111/nmo.12718. Epub 2015 Nov 7.
citation: Parkman HP, Hallinan EK, Hasler WL, Farrugia G, Koch KL, Calles J, Snape WJ, Abell TL, Sarosiek I, McCallum RW, Nguyen L, Pasricha PJ, Clarke J, Miriel L, Lee L, Tonascia J, Hamilton F; NIDDK Gastroparesis Clinical Research Consortium (GpCRC). Nausea and vomiting in gastroparesis: similarities and differences in idiopathic and diabetic gastroparesis. Neurogastroenterol Motil. 2016 Dec;28(12):1902-1914. doi: 10.1111/nmo.12893. Epub 2016 Jun 27.
citation: Hasler WL, Wilson LA, Parkman HP, Nguyen L, Abell TL, Koch KL, Pasricha PJ, Snape WJ, Farrugia G, Lee L, Tonascia J, Unalp-Arida A, Hamilton F; NIDDK Gastroparesis Clinical Research Consortium (GpCRC). Bloating in gastroparesis: severity, impact, and associated factors. Am J Gastroenterol. 2011 Aug;106(8):1492-502. doi: 10.1038/ajg.2011.81. Epub 2011 Apr 12.
citation: Abell TL, Bernstein RK, Cutts T, Farrugia G, Forster J, Hasler WL, McCallum RW, Olden KW, Parkman HP, Parrish CR, Pasricha PJ, Prather CM, Soffer EE, Twillman R, Vinik AI. Treatment of gastroparesis: a multidisciplinary clinical review. Neurogastroenterol Motil. 2006 Apr;18(4):263-83. doi: 10.1111/j.1365-2982.2006.00760.x.
citation: 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.
citation: Parkman HP, Yates KP, Hasler WL, Nguyan L, Pasricha PJ, Snape WJ, Farrugia G, Calles J, Koch KL, Abell TL, McCallum RW, Petito D, Parrish CR, Duffy F, Lee L, Unalp-Arida A, Tonascia J, Hamilton F; NIDDK Gastroparesis Clinical Research Consortium. Dietary intake and nutritional deficiencies in patients with diabetic or idiopathic gastroparesis. Gastroenterology. 2011 Aug;141(2):486-98, 498.e1-7. doi: 10.1053/j.gastro.2011.04.045. Epub 2011 Apr 28.
citation: 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.