Study of Gastric Motility in Eosinophilic Gastritis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-59
SponsorChildren's Hospital Medical Center, Cincinnati
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Eosinophilic gastritis (EG) defined as at least one endoscopy with histopathologic evidence of ≥ 30 eosinophils in 5 or more high powered fields (hpf's) with associated symptoms of EG.
Patient reported symptoms starting at least one year or more prior to screening consistent with a diagnosis of EG: nausea, vomiting, early satiety, abdominal pain/bloating, regurgitation, diarrhea.
Symptoms suggestive of a possible gastric motility disorder during the 60 days prior to screening including: nausea, vomiting, early satiety, post-prandial feeling of fullness or bloating.
Tolerance and willingness to consume the oatmeal meal in this study.
Disqualifiers
Diagnosis of eosinophilic enteritis.
Inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis).
Known disorders associated with eosinophilic gastrointestinal (GI) diseases (e.g., D 816 V Kit+ systemic mastocytosis, Marfan syndrome or Loey's Dietz Syndrome).
Known inflammatory or autoimmune disorders associated with gastric dysmotility such as systemic sclerosis, lupus or eosinophilic fasciitis.
Trial population
Males and females aged 18 and 59 years old with EG.
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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]Secondary outcomes
1
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])2
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]3
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])Sponsors and contacts
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Source ClinicalTrials.gov