NCT03320369CompletedNot Applicable
Effect of Elemental Diet on Adult Patients With Eosinophilic Gastroenteritis
Children's Hospital Medical Center, Cincinnati1 site in 1 country18 target enrollmentStarted: September 5, 2017Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Percent of Participants in Complete Histologic Remission
Study Overview
Brief Summary
The purpose of this study is to investigate the effect of an elemental diet on adult patients with Eosinophilic Gastroenteritis
Detailed Description
This prospective interventional study will investigate the effect of an exclusive, six week elemental diet in adult patients with Eosinophilic Gastroenteritis
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •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.
Arms & Interventions
Treatment
Other
Elemental formula Intervention: Elemental Diet Therapy
Intervention: Elemental Diet Therapy (Other)
Outcomes
Primary Outcomes
Percent of Participants in Complete Histologic Remission
Time Frame: 6 weeks after treatment
Percent of patients who have achieved complete histologic remission. Complete histologic remission is defined as normalization of gastric mucosal eosinophilia (histology with less than the diagnostic threshold levels of mucosal eosinophilia (\<30 eosinophils per high power field (HPF))
Secondary Outcomes
- Percent of Participants in Partial Histologic Remission(6 weeks after treatment)
- Mean Change From Baseline in Maximum Eosinophil Count(Baseline, 6 weeks after treatment)
- Change From Baseline in Total Gastric Endoscopic Reference Score(Baseline, 6 weeks after treatment)
- Change From Baseline in Symptoms of Dyspepsia (SODA)(Baseline, 6 weeks after treatment)
- Change From Baseline in Promis Anxiety(Baseline, 6 weeks after treatment)
Investigators
Study Sites (1)
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