Examining gastric motility in patients with eosinophilic gastritis
Pilot Assessment to Find Evidence of Gastric Motility Abnormalities in Eosinophilic Gastric Disorders
Children's Hospital Medical Center, Cincinnati · NCT05229432
This study is trying to see if people with eosinophilic gastritis have problems with how their stomach moves and digests food.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 59 Years |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati (other) |
| Locations | 3 sites (Chicago, Illinois and 2 other locations) |
| Trial ID | NCT05229432 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with eosinophilic gastritis who exhibit symptoms consistent with gastric motility disorders.
Not a fit: Patients with eosinophilic enteritis or other significant gastrointestinal disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the diagnosis and management of gastric motility disorders in patients with eosinophilic gastritis.
How similar studies have performed: While similar studies on gastric motility disorders exist, this specific focus on eosinophilic gastritis and its implications for gastric function is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chicago, Illinois and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Eosinophilic Gastritis, Gastroparesis, Gastric Motility Disorder, Gastritis, Eosinophilic Gastrointestinal Disorders, Gastric Dysfunction, Gastric Dysmotility, Eosinophils