Effect of Elemental Diet on Adult Patients With Eosinophilic Gastroenteritis
NCT ID: NCT03320369
Last Updated: 2020-10-27
Study Results
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View full resultsBasic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2017-09-05
2019-10-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
Elemental formula Intervention: Elemental Diet Therapy
Elemental Diet Therapy
Elemental diet is a formula composed of amino-acids, carbohydrates, and lipids that is 100% nutritionally complete
Interventions
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Elemental Diet Therapy
Elemental diet is a formula composed of amino-acids, carbohydrates, and lipids that is 100% nutritionally complete
Eligibility Criteria
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Inclusion Criteria
2. Males and Females ≥18 to 65 years of age;
3. Have diagnosis of EG/EGE
4. Have histologically confirmed active disease \> 30 eosinophils/hpf
5. Symptomatic (have experienced symptoms within the last one months prior to enrollment).
6. Female subjects of childbearing potential must have a negative pregnancy test upon study entry
7. 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
2. Secondary causes of gastrointestinal and peripheral eosinophilia
3. Eosinophilic infiltration isolated to the esophagus.
4. Pregnancy
5. Immunodeficiency states
6. 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.
7. 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.
8. Have been on an elemental diet previously for six weeks with follow up endoscopy completed.
9. Have participated in any investigative drug study within 6 weeks prior to study entry.
10. Unable to complete study procedures including endoscopy.
11. 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.
18 Years
65 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Office of Rare Diseases (ORD)
NIH
National Center for Advancing Translational Sciences (NCATS)
NIH
Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Principal Investigators
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Nirmala Gonsalves, M.D.
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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Northwestern University
Chicago, Illinois, United States
Countries
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References
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Gonsalves N, Doerfler B, Zalewski A, Yang GY, Martin LJ, Zhang X, Shoda T, Brusilovsky M, Aceves S, Thompson K, Rudman Spergel AK, Furuta G, Rothenberg ME, Hirano I. Prospective study of an amino acid-based elemental diet in an eosinophilic gastritis and gastroenteritis nutrition trial. J Allergy Clin Immunol. 2023 Sep;152(3):676-688. doi: 10.1016/j.jaci.2023.05.024. Epub 2023 Jul 18.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related info
Other Identifiers
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2017-2766
Identifier Type: -
Identifier Source: org_study_id