Study of Gastric Motility in Eosinophilic Gastritis

Launched by CHILDREN'S HOSPITAL MEDICAL CENTER, CINCINNATI · Jan 24, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how eosinophilic gastritis (EG) affects the movement of food through the stomach, a condition known as gastric motility impairment. The researchers believe that many people with EG may experience problems with how their stomach works, but these issues are often missed because standard tests are not suitable for everyone. The study aims to better understand these gastric problems by observing patients who have been diagnosed with EG and are experiencing related symptoms like nausea, vomiting, and abdominal discomfort.

To participate in this study, individuals must have a confirmed diagnosis of eosinophilic gastritis, which is identified through a procedure called endoscopy that shows a specific number of eosinophils (a type of white blood cell) in their stomach tissue. Eligible participants should have experienced symptoms for at least a year and must be willing to eat a specific oatmeal meal for the study. However, people with certain other gastrointestinal diseases, severe health conditions, or recent surgeries will not be included. Participants can expect to contribute to important research that may help improve understanding and treatment of gastric issues related to eosinophilic gastritis.

Gender

ALL

Eligibility 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.