Status:
RECRUITING
Study of Gastric Motility in Eosinophilic Gastritis
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Eosinophilic Gastritis
Gastroparesis
Eligibility:
All Genders
18-59 years
Brief Summary
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 th...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Uncontrolled diabetes or known diabetic complications of gastroparesis, neuropathy or nephropathy.
- Taking opioid agents in the 2 weeks prior to screening and throughout the study.
- History of strictures in the small bowel or stomach (e.g., pyloric stenosis) or gastric surgeries or procedures such as pyloromyotomy, pyloric dilation, pyloric resection, vagotomy, bariatric surgery or post-Nissen fundoplication or antrectomy with Billroth I, Billroth II or Roux-en-Y gastrojejunostomy.
- Past or current medical problems or findings such as: advanced liver disease (Child's B or C), acute or chronic renal disease (serum creatinine \> 3 mg/dL), neurologic disease (e.g., dysautonomia), achalasia and adrenal insufficiency.
Key Trial Info
Start Date :
January 25 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05229432
Start Date
January 25 2023
End Date
December 1 2026
Last Update
May 18 2025
Active Locations (3)
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1
Northwestern University
Chicago, Illinois, United States, 60208
2
The National Institutes of Health
Bethesda, Maryland, United States, 20892
3
University of Utah
Salt Lake City, Utah, United States, 84112