Study of Gastric Motility in Eosinophilic Gastritis (OAT-FEED)

Cincinnati Children's Hospital Medical Center

Status: Enrolling

Conditions: Gastric Motility Disorder; Gastroparesis; Eosinophilic Gastritis

Study type: Observational

Funder types: Other

Identifiers

NCT05229432

2021-0349

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

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.