Status:
COMPLETED
Effect of Elemental Diet on Adult Patients With Eosinophilic Gastroenteritis
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Eosinophilic Gastroenteritis
Eligibility:
All Genders
18-65 years
Phase:
NA
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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2019
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03320369
Start Date
September 5 2017
End Date
October 5 2019
Last Update
October 27 2020
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60208