Non-endoscopic Tracking of Disease Activity in Eosinophilic Esophagitis

NCT03834298 | Withdrawn

• 1 other identifier: 19-0018
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Eosinophilic Esophagitis

Outcome Measures

Primary Outcomes (3)

• Disease Remission as Measured by Esophageal String Test (EST) Score (EoEScore)

  Disease remission will be an EoEScore \<0.36, the score below which the patient has a very low probability of having an eosinophil count \> 15 eos/HPF = active EoE. This decision rule is associated with a sensitivity of 0.92 and specificity of 0.28 for having active EoE.

  6 weeks

• Disease Remission as Measured by Esophageal String Test (EST) Score (EoEScore)

  Disease remission will be an EoEScore \<0.36, the score below which the patient has a very low probability of having an eosinophil count \> 15 eos/HPF = active EoE. This decision rule is associated with a sensitivity of 0.92 and specificity of 0.28 for having active EoE. This 2 week time point will be a co-primary outcome measure.

  2 weeks

• Disease Remission as Measured by Esophageal String Test (EST) Score (EoEScore)

  Disease remission will be an EoEScore \<0.36, the score below which the patient has a very low probability of having an eosinophil count \> 15 eos/HPF = active EoE. This decision rule is associated with a sensitivity of 0.92 and specificity of 0.28 for having active EoE. This 4 week time point will be a co-primary outcome measure.

  4 weeks

Secondary Outcomes (4)

• Change in Symptom Severity in Participants Age 18-65 as Measured by Eosinophilic Esophagitis Activity Index (EESAI)

  Baseline and 6 weeks

• Change in Symptom Severity in Participants Age 7-18 as Measured by Pediatric Eosinophilic Esophagitis Symptom Severity (PEESS v 2.)

  Baseline and 6 weeks

• Time to Disease Recurrence as Measured by EST score

  4 weeks after food re-introduction

• Time to Disease Recurrence as Measured by EST score

  2 weeks after food re-introduction

Study Arms (1)

Four Food Elimination Diet (FFED)

EXPERIMENTAL

There is one arm to the study. All participants meeting eligibility will be assigned to intervention / treatment with a previously defined four food elimination diet (FFED) (Aim 1). This is a longitudinal study in which outcome measures including symptoms, QOL and inflammation at baseline and at 2, 4 and 6 weeks after starting stand of care (SOC) FFED will be measured. Participants meeting eligibility for Aim 2 will have foods added back to the diet using a specified protocol.

Other: Four Food Elimination Diet

Interventions

Four Food Elimination Diet OTHER

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.

Four Food Elimination Diet (FFED)

Eligibility Criteria

• Age: 7 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Northwestern University: collaborator
• Ann & Robert H Lurie Children's Hospital of Chicago: collaborator

MeSH Terms

Conditions

Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Calies Menard-Katcher, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2019
• First Posted: February 7, 2019
• Study Start: June 1, 2021
• Primary Completion: August 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 31, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share