Health Trials

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

Qualifiers

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 design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed

Locations

3
Northwestern University60208, ChicagoIllinois, United States
The National Institutes of Health20892, BethesdaMaryland, United States
University of Utah84112, Salt Lake CityUtah, United States

Sponsors and collaborators

Children's Hospital Medical Center, Cincinnati

Lead sponsor

Source ClinicalTrials.gov