Study of Gastric Motility in Eosinophilic Gastritis

Официальное название

Pilot Assessment to Find Evidence of Gastric Motility Abnormalities in Eosinophilic Gastric Disorders

Обзор

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.

Первичные конечные точки

• 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). [Срок оценки: Gastric Emptying Scintigraphy [0 minutes, 30 minutes, 60 minutes, 120 minutes and 180 minutes]]

Вторичные конечные точки (3)

• Relationship between gastric dysfunction and eosinophilic gastritis disease activity measured via peak and mean eosinophils/hpf in the stomach. [Срок оценки: Endoscopy Procedure (Peak and mean eosinophils/hpf [Date of GES + 2-10 days])]
• Relationship between gastric dysfunction and eosinophilic gastritis disease activity measured via symptomology and quality of life questionnaires. [Срок оценки: Questionnaires [screening/baseline visit, 2 weeks prior to date of GES up to completion of the endoscopy]]
• Relationship between gastric dysfunction and eosinophilic gastritis disease activity measured via assessing endoscopic features of the stomach. [Срок оценки: Endoscopy Procedure (Endoscopic features [Date of GES + 2-10 days])]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

США · 3 центра

• Northwestern University — Chicago
• The National Institutes of Health — Bethesda
• University of Utah — Salt Lake City

Идентификаторы

NCT: NCT05229432 · 2021-0349

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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