Recruiting

Gastric Motility

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT05229432

Conditions

Eosinophilic Gastritis

Gastroparesis

Gastric Motility Disorder

Eligibility Criteria

Sex: All

Age: 18 - 59

Healthy Volunteers: Not accepted

Study Details

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

Eosinophilic Gastritis

Gastroparesis

Gastric Motility Disorder

Study ID

NCT05229432

Start date

Jan 25, 2023

Status verified date

May, 2025

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 59

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Primary outcome 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). [ Time Frame: Gastric Emptying Scintigraphy [0 minutes, 30 minutes, 60 minutes, 120 minutes and 180 minutes] ]

Central Contacts and Locations

Central contacts

Regina Yearout

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

Locations

Northwestern University

Recruiting

Chicago, Illinois, United States, 60208

Contacts

Rose Arrieta

312-695-5878rarrieta@northwestern.edu

Principal Investigator:

Nirmala Gonsalves, MD

The National Institutes of Health

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

Perla Adames-Castillo, RN

301-402-5969perla.adamescastillo@nih.gov

Megan Koch

megan.koch@nih.gov

Principal Investigator:

Paneez Khoury, MD

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Amy Nichols

Amy.Nichols@hsc.utah.edu

Principal Investigator:

Kathryn Peterson, MD

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Mar 31, 2026

Last verified

May, 2025

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-11. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2026-03-31. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.