Status:
WITHDRAWN
Non-endoscopic Tracking of Disease Activity in Eosinophilic Esophagitis
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Northwestern University
Ann & Robert H Lurie Children's Hospital of Chicago
Conditions:
Eosinophilic Esophagitis
Eligibility:
All Genders
7-65 years
Phase:
NA
Brief Summary
To prospectively determine the natural history of inflammation resolution following initiation of diet treatment and to optimize the diet treatment of patients with EoE through the use of a non-endosc...
Detailed Description
This is an adult and pediatric prospective, longitudinal study in which we will measure symptoms, QOL and inflammation at baseline and again at 2, 4 and 6 weeks after starting stand of care (SOC) four...
Eligibility Criteria
Inclusion
- Participant must be able to understand and provide informed consent
- Males and Females ≥7 years of age to 65 years of age
- Have diagnosis of EoE
- Have histologically confirmed active disease ≥15 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
Exclusion
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol
- Secondary causes of eosinophilia
- Pregnancy
- Immunodeficiency states
- Have participated in any investigative drug study within 6 weeks prior to study entry
- Unable to complete study procedures including endoscopy
- Luminal stricture identified \<13mm which would prevent passage of the EST and prevent assessment of mucosal inflammation
- 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 :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03834298
Start Date
June 1 2021
End Date
December 1 2023
Last Update
March 31 2023
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