RECRUITING

Study of Gastric Motility in Eosinophilic Gastritis

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Conditions

Eosinophilic GastritisGastroparesisGastric Motility DisorderGastritisEosinophilic Gastrointestinal DisordersGastric DysfunctionGastric DysmotilityEosinophilsEosinophiliaEosinophilic DisordersDigestive System DiseasesImmune System DiseasesStomach DiseasesGastric Emptying ScintigraphyEndoscopy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-01-25
Study Completion:2025-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05229432

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.

Ages Eligible for Study:18 Years to 59 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * 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.
  3. * 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.
  4. * Tolerance and willingness to consume the oatmeal meal in this study.
  1. * Diagnosis of eosinophilic enteritis.
  2. * Inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis).
  3. * Known disorders associated with eosinophilic gastrointestinal (GI) diseases (e.g., D 816 V Kit+ systemic mastocytosis, Marfan syndrome or Loey's Dietz Syndrome).
  4. * Known inflammatory or autoimmune disorders associated with gastric dysmotility such as systemic sclerosis, lupus or eosinophilic fasciitis.
  5. * Uncontrolled diabetes or known diabetic complications of gastroparesis, neuropathy or nephropathy.
  6. * Taking opioid agents in the 2 weeks prior to screening and throughout the study.
  7. * 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.
  8. * 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.

Contacts and Locations

Study Contact

Lauren Turner, MPH
CONTACT
(513) 803-5446
Lauren.Turner@cchmc.org

Principal Investigator

Paneez Khoury, MD
STUDY_CHAIR
National Institutes of Health (NIH)

Study Locations (Sites)

Northwestern University
Chicago, Illinois, 60208
United States
The National Institutes of Health
Bethesda, Maryland, 20892
United States
University of Utah
Salt Lake City, Utah, 84112
United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

  • Paneez Khoury, MD, STUDY_CHAIR, 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 Registration Dates

Study Start Date2023-01-25
Study Completion Date2025-06-01

Study Record Updates

Study Start Date2023-01-25
Study Completion Date2025-06-01

Terms related to this study

Keywords Provided by Researchers

  • Gastritis
  • Eosinophilic Gastrointestinal Disorders
  • Gastric Dysfunction
  • Gastric Dysmotility
  • Eosinophils
  • Eosinophilia
  • Eosinophilic Disorders
  • Digestive System Diseases
  • Immune System Diseases
  • Stomach Diseases
  • Gastric Emptying Scintigraphy
  • Endoscopy

Additional Relevant MeSH Terms

  • Eosinophilic Gastritis
  • Gastroparesis
  • Gastric Motility Disorder