Study of Gastric Motility in Eosinophilic Gastritis (OAT-FEED)

March 26, 2026 updated by: Children's Hospital Medical Center, Cincinnati

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60208
        • Recruiting
        • Northwestern University
        • Contact:
        • Principal Investigator:
          • Nirmala Gonsalves, MD
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • Recruiting
        • The National Institutes of Health
        • Contact:
        • Contact:
        • Principal Investigator:
          • Paneez Khoury, MD
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • University of Utah
        • Contact:
        • Principal Investigator:
          • Kathryn Peterson, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Time Frame: Gastric Emptying Scintigraphy [0 minutes, 30 minutes, 60 minutes, 120 minutes and 180 minutes]

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship between gastric dysfunction and eosinophilic gastritis disease activity measured via peak and mean eosinophils/hpf in the stomach.
Time Frame: Endoscopy Procedure (Peak and mean eosinophils/hpf [Date of GES + 2-10 days])

The relationship between gastric dysfunction and eosinophilic gastritis disease activity, as represented by eosinophil levels, will be measured via the correlation between the time it takes the oatmeal to leave the stomach and the amount of eosinophils that the pathologists count in pieces of tissue (biopsies) from the stomach obtained during the endoscopy procedure.

The higher the number of eosinophils in the tissue, the more active the EG disease is considered to be.
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.
Time Frame: Questionnaires [screening/baseline visit, 2 weeks prior to date of GES up to completion of the endoscopy]

The correlation between the time it takes the oatmeal to leave the stomach and patient-reported data on the following questionnaires: 'Patient Assessment of Gastrointestinal Symptom Severity Index' (PAG-SYM), 'Patient Assessment of Gastrointestinal Quality of Life' (PAGI-QoL), 'Patient Reported Outcome Measurement Information System' (PROMIS) and 'Symptoms of Eosinophilic Gastritis' (EoG-SQ).

PAG-SYM: 20 items each with a 6-point Likert scale ranging from 0="None'' to 5="Very Severe''. Higher scores are associated with more severe symptoms.

PAGI-QoL: 30 items each with a 6-point Likert scale ranging from 0="None of the time'' to 5="All of the time''. A higher score means a higher quality of life.

PROMIS: 29 items each with a 5-point Likert scale. A higher score represents a worse quality of life.

EoG-SQ: the severity of EG symptoms on a scale of 0 to 10. The frequency of symptoms on a scale of 0 to 7. Higher scores indicate a greater symptom burden.
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.
Time Frame: Endoscopy Procedure (Endoscopic features [Date of GES + 2-10 days])

The relationship between gastric dysfunction and eosinophilic gastritis disease activity measured via endoscopic features utilizing the 'Eosinophilic Gastritis Endoscopy Score' (EoG-REFS). During the endoscopy, the physician will look at the stomach and record what it looks like on the EoG-REFS assessment.

EoG-REFS scoring: Utilizes standardized criteria for the presence and degree of 5 major endoscopic features (granularity, nodularity, erosion/ulceration, friability, erythema). Total score is the maximum score of the 5 feature scores from the body, antrum or fundus. Total scores range from 0 - 14. Higher scores indicate more severe endoscopic findings. There is also a 'Global Assessment of Endoscopic Severity' with a scale from 0 (normal) to 10 (severe).
Endoscopy Procedure (Endoscopic features [Date of GES + 2-10 days])

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Investigators

  • Study Chair: Paneez Khoury, MD, National Institutes of Health (NIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 20, 2021

First Submitted That Met QC Criteria

January 24, 2022

First Posted (Actual)

February 8, 2022

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-0349

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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