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Non-endoscopic Tracking of Disease Activity in Eosinophilic Esophagitis

NCT03834298 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-03-31

No results posted yet for this study

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-endoscopic tracking device, the esophageal string test (EST).

Conditions

  • Eosinophilic Esophagitis

Interventions

OTHER

Four Food Elimination Diet

Food allergens are thought to initiate eosinophilic inflammation and dietary elimination of trigger allergens is an effective treatment for EoE. Previous work demonstrates that in both children and adult EoE patients, the food antigens including cow's milk, wheat, egg, soy, peanut/tree nut and fish/shell fish, are the most common food triggers causing esophageal inflammation. Participants will be assigned to single arm treatment / intervention with a diet restricted of the four most common food allergens, milk, soy, wheat and egg, or a four food elimination diet (FFED). With the goal to optimize diet treatment, in Aim 2, eligible participants will undergo sequential food reintroductions based on protocol.

Sponsors & Collaborators

  • Northwestern University

    collaborator OTHER

  • Ann & Robert H Lurie Children's Hospital of Chicago

    collaborator OTHER

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Calies Menard-Katcher, MD · University of Colorado, Denver

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2023-08-01
Completion
2023-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03834298 on ClinicalTrials.gov