Study of Gastric Motility in Eosinophilic Gastritis

NCT05229432 | Recruiting

• 1 other identifier: 2021-0349
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 3

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.

Conditions

Gastroparesis; Eosinophilic Gastritis; 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

Outcome Measures

Primary Outcomes (1)

• 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).

  A gastric motility disorder will be defined as the presence of delayed gastric emptying ( \> 8% of an oatmeal meal remaining in the stomach at 3 hours) measured by gastric emptying scintigraphy (GES). Specifically, the participant will consume oatmeal with a small amount of mixed-in radioactive material. After consuming the meal, a gastric emptying scintigraphy scan will take images at the following timepoints: 0 minutes, 30 minutes, 60 minutes, 120 minutes and 180 minutes.

  Gastric Emptying Scintigraphy [0 minutes, 30 minutes, 60 minutes, 120 minutes and 180 minutes]

Secondary Outcomes (3)

• Relationship between gastric dysfunction and eosinophilic gastritis disease activity measured via peak and mean eosinophils/hpf in the stomach.

  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.

  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.

  Endoscopy Procedure (Endoscopic features [Date of GES + 2-10 days])

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Males and females aged 18 and 59 years old with EG.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (3)

Northwestern University

Chicago, Illinois, 60208, United States

RECRUITING

The National Institutes of Health

Bethesda, Maryland, 20892, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Conditions

Eosinophilic enteropathy; Gastroparesis; Gastritis; Eosinophilic Esophagitis; Eosinophilia; Digestive System Diseases; Immune System Diseases; Stomach Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastroenteritis; Esophagitis; Esophageal Diseases; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity

Study Officials

• Paneez Khoury, MD

  National Institutes of Health (NIH)

  STUDY CHAIR

Central Study Contacts

Regina Yearout

CONTACT

(513) 517-2108; Regina.Yearout@cchmc.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: February 8, 2022
• Study Start: January 25, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 31, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)