An observational study in Eosinophilic Gastritis, Gastroparesis and Gastric Motility Disorder, sponsored by Children's Hospital Medical Center, Cincinnati. Recruiting at 3 sites in United States. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2026-03-31.
Sponsored by Children's Hospital Medical Center, Cincinnati · Observational
Purpose:
The study is a cross-sectional observational study designed to determine if eosinophilic gastritis (EG) results in gastric motility impairment.
Hypothesis:
Gastric dysfunction occurs in the natural history of EG but is underdiagnosed due, in part, to contraindications to the use of the standard meals used in gastric emptying studies.
28 studies on the registry are indexed under Eosinophilic enteropathy; 5 are open to participants now.
This study's planned enrollment of 30 is below the median of 341 across 10 observational studies indexed under Eosinophilic enteropathy.
Browse Eosinophilic enteropathy studies →Children's Hospital Medical Center, Cincinnati is the lead sponsor of 673 studies on the registry; 130 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 31 (54%) have results posted.
Counted across the registry records on this site, refreshed daily.
Males and females aged 18 and 59 years old with EG.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Prevalence of gastric motility disorders determined via gastric emptying scintigraphy (GES) imaging at timepoints 0 minutes, 30 minutes, 60 minutes, 120 minutes and 180 minutes (% of meal remaining/time).
A gastric motility disorder will be defined as the presence of delayed gastric emptying ( \> 8% of an oatmeal meal remaining in the stomach at 3 hours) measured by gastric emptying scintigraphy (GES). Specifically, the participant will consume oatmeal with a small amount of mixed-in radioactive material. After consuming the meal, a gastric emptying scintigraphy scan will take images at the following timepoints: 0 minutes, 30 minutes, 60 minutes, 120 minutes and 180 minutes.
Time frame: Gastric Emptying Scintigraphy [0 minutes, 30 minutes, 60 minutes, 120 minutes and 180 minutes]
Relationship between gastric dysfunction and eosinophilic gastritis disease activity measured via peak and mean eosinophils/hpf in the stomach.
The relationship between gastric dysfunction and eosinophilic gastritis disease activity, as represented by eosinophil levels, will be measured via the correlation between the time it takes the oatmeal to leave the stomach and the amount of eosinophils that the pathologists count in pieces of tissue (biopsies) from the stomach obtained during the endoscopy procedure. The higher the number of eosinophils in the tissue, the more active the EG disease is considered to be.
Time frame: Endoscopy Procedure (Peak and mean eosinophils/hpf [Date of GES + 2-10 days])
Relationship between gastric dysfunction and eosinophilic gastritis disease activity measured via symptomology and quality of life questionnaires.
The correlation between the time it takes the oatmeal to leave the stomach and patient-reported data on the following questionnaires: 'Patient Assessment of Gastrointestinal Symptom Severity Index' (PAG-SYM), 'Patient Assessment of Gastrointestinal Quality of Life' (PAGI-QoL), 'Patient Reported Outcome Measurement Information System' (PROMIS) and 'Symptoms of Eosinophilic Gastritis' (EoG-SQ). PAG-SYM: 20 items each with a 6-point Likert scale ranging from 0="None'' to 5="Very Severe''. Higher scores are associated with more severe symptoms. PAGI-QoL: 30 items each with a 6-point Likert scale ranging from 0="None of the time'' to 5="All of the time''. A higher score means a higher quality of life. PROMIS: 29 items each with a 5-point Likert scale. A higher score represents a worse quality of life. EoG-SQ: the severity of EG symptoms on a scale of 0 to 10. The frequency of symptoms on a scale of 0 to 7. Higher scores indicate a greater symptom burden.
Time frame: Questionnaires [screening/baseline visit, 2 weeks prior to date of GES up to completion of the endoscopy]
Relationship between gastric dysfunction and eosinophilic gastritis disease activity measured via assessing endoscopic features of the stomach.
The relationship between gastric dysfunction and eosinophilic gastritis disease activity measured via endoscopic features utilizing the 'Eosinophilic Gastritis Endoscopy Score' (EoG-REFS). During the endoscopy, the physician will look at the stomach and record what it looks like on the EoG-REFS assessment. EoG-REFS scoring: Utilizes standardized criteria for the presence and degree of 5 major endoscopic features (granularity, nodularity, erosion/ulceration, friability, erythema). Total score is the maximum score of the 5 feature scores from the body, antrum or fundus. Total scores range from 0 - 14. Higher scores indicate more severe endoscopic findings. There is also a 'Global Assessment of Endoscopic Severity' with a scale from 0 (normal) to 10 (severe).
Time frame: Endoscopy Procedure (Endoscopic features [Date of GES + 2-10 days])
Plan to share: No
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