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N/A N=18 Treatment

Effect of Elemental Diet on Adult Patients With Eosinophilic Gastroenteritis

Eosinophilic Gastroenteritis

Enrolled (actual)
18
Serious AEs
5.6%
Results posted
Sep 2020
Primary outcome: Primary: Percent of Participants in Complete Histologic Remission — 100 percentage of participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Elemental Diet Therapy (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Children's Hospital Medical Center, Cincinnati
Primary completion
Sep 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Percent of Participants in Complete Histologic Remission
100
SECONDARY
Percent of Participants in Partial Histologic Remission
93
SECONDARY
Mean Change From Baseline in Maximum Eosinophil Count
63.1; -46.9 <0.001 sig
SECONDARY
Change From Baseline in Total Gastric Endoscopic Reference Score
5; -3
SECONDARY
Change From Baseline in Symptoms of Dyspepsia (SODA)
21.8; 15.7; 9.2; -6.9; -1.6; 6.1
SECONDARY
Change From Baseline in Promis Anxiety
52.6; -2.7

Summary

The purpose of this study is to investigate the effect of an elemental diet on adult patients with Eosinophilic Gastroenteritis

Eligibility Criteria

Inclusion Criteria

  • Participant must be able to understand and provide informed consent
  • Males and Females ≥18 to 65 years of age;
  • Have diagnosis of EG/EGE
  • Have histologically confirmed active disease > 30 eosinophils/hpf
  • Symptomatic (have experienced symptoms within the last one months prior to enrollment).
  • Female subjects of childbearing potential must have a negative pregnancy test upon study entry
  • Female (and male) subjects with reproductive potential, must agree to use FDA approved methods of birth control for the duration of the study-specific methods may be listed, if applicable

Exclusion Criteria

  • Inability or unwillingness of a participant to give written informed consent or comply with study protocol
  • Secondary causes of gastrointestinal and peripheral eosinophilia
  • Eosinophilic infiltration isolated to the esophagus.
  • Pregnancy
  • Immunodeficiency states
  • Have been treated with topical swallowed steroids within the last 6 weeks or systemic steroids within the last 2 months unless repeat endoscopy is performed and shows active inflammation on these therapies in which case these medications will be allowed to be continued without dose escalation.
  • Have taken immunosuppression medication or immunomodulators within 2 months of the study unless the recent/baseline endoscopy has active histologic inflammation while on these medications. In this case, these medications will be permitted to be continued as long as the dose is not escalated during the treatment phase.
  • Have been on an elemental diet previously for six weeks with follow up endoscopy completed.
  • Have participated in any investigative drug study within 6 weeks prior to study entry.
  • Unable to complete study procedures including endoscopy.
  • Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03320369). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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