Clinical trial NCT05229432: Study of Gastric Motility in Eosinophilic Gastritis
Official title: Pilot Assessment to Find Evidence of Gastric Motility Abnormalities in Eosinophilic Gastric Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Eosinophilic Gastritis
Gastroparesis
Gastric Motility Disorder
Keywords: Gastritis
Eosinophilic Gastrointestinal Disorders
Gastric Dysfunction
Gastric Dysmotility
Eosinophils
Eosinophilia
Eosinophilic Disorders
Digestive System Diseases
Immune System Diseases
Stomach Diseases
Gastric Emptying Scintigraphy
Endoscopy
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males and females aged 18 and 59 years old with EG.

Brief summary: 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: 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.

Primary outcomes:
measure: Prevalence of gastric motility disorders determined via gastric emptying scintigraphy (GES) imaging at timepoints 0 minutes, 30 minutes, 60 minutes, 120 minutes and 180 minutes (% of meal remaining/time).
timeFrame: Gastric Emptying Scintigraphy [0 minutes, 30 minutes, 60 minutes, 120 minutes and 180 minutes]
Secondary outcomes:
measure: Relationship between gastric dysfunction and eosinophilic gastritis disease activity measured via peak and mean eosinophils/hpf in the stomach.
timeFrame: Endoscopy Procedure (Peak and mean eosinophils/hpf [Date of GES + 2-10 days])
measure: Relationship between gastric dysfunction and eosinophilic gastritis disease activity measured via symptomology and quality of life questionnaires.
timeFrame: Questionnaires [screening/baseline visit, 2 weeks prior to date of GES up to completion of the endoscopy]
measure: Relationship between gastric dysfunction and eosinophilic gastritis disease activity measured via assessing endoscopic features of the stomach.
timeFrame: Endoscopy Procedure (Endoscopic features [Date of GES + 2-10 days])
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Bethesda
country: United States
facility: The National Institutes of Health
state: Maryland
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: National Institutes of Health (NIH)
name: Paneez Khoury, MD
role: STUDY_CHAIR
References: