Study of Gastric Motility in Eosinophilic Gastritis

Pilot Assessment to Find Evidence of Gastric Motility Abnormalities in Eosinophilic Gastric Disorders

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.

Inclusion Criteria:

• 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 Criteria:

• 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.