Examining gastric motility in patients with eosinophilic gastritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate whether eosinophilic gastritis (EG) leads to gastric motility impairment. It will assess patients with a confirmed diagnosis of EG and evaluate their gastric function through symptom reporting and specific meal tolerance. The study hypothesizes that gastric dysfunction is a common but underdiagnosed aspect of EG, potentially due to challenges in standard diagnostic procedures. By focusing on patient-reported symptoms and histopathological evidence, the study seeks to enhance understanding of gastric motility disorders associated with EG.

Why it matters

Who can join: the full rules

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.

Where it's running

• Northwestern University
  Chicago, Illinois, United States Recruiting
• The National Institutes of Health
  Bethesda, Maryland, United States Recruiting
• University of Utah
  Salt Lake City, Utah, United States Recruiting

Study contacts

• Study coordinator: Regina Yearout
• Email: Regina.Yearout@cchmc.org
• Phone: (513) 517-2108

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.