CEGIR 7808: Use of Unsedated Transnasal Esophagoscopy (TNE) to Monitor Dietary Management of Eosinophilic Esophagitis in Children

NCT03342391 | Completed DMC

• 1 other identifier: 2017-0237
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the effectiveness of utilizing Transnasal Esophagoscopy as a means of monitoring Eosinophilic Esophagitis patients.

Conditions

Eosinophilic Esophagitis

Outcome Measures

Primary Outcomes (1)

• Histological Improvement

  To prospectively and serially evaluate the recurrence of esophageal eosinophilia (\>15 eosinophils per high power field) after a clinical single food antigen introduction OR removal of swallowed topical steroid therapy by the subject's clinical allergist or gastroenterologist in children with EoE using unsedated Transnasal Endoscopy/Esophagoscopy.

  6 weeks

Secondary Outcomes (3)

• Endoscopic Appearances/Histological Findings

  6 weeks

• Sample Size

  6 weeks

• Decision to participate

  6 weeks

Study Arms (1)

Treatment Phase

OTHER

Treatment Phase will evaluate the effectiveness of Transnasal Esophagoscopy (TNE) as an acceptable form of monitoring Eosinophilic Esophagitis

Other: Transnasal esophagoscopy

Interventions

Transnasal esophagoscopy OTHER

single food antigen introduction OR removal of topical swallowed steroid therapy followed by surveillance utilizing TNE

Treatment Phase

Eligibility Criteria

• Age: 5 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participant must be able to understand and provide informed consent/assent
• Males and females ages 5-22 years of age
• History of an established diagnosis of EoE
• Recent EGD or TNE (with in past 1 year) showing EoE remission (e.g. \<15 x eosinophils/hpf) and currently without significant symptoms attributed to EoE.
• On a four food or less elimination diet not including or counting foods restricted at time of EoE diagnosis OR on swallowed topical steroid therapy with any number of foods eliminated from the diet.
• Female subjects of childbearing potential must have a negative pregnancy test upon study entry
• Female subjects with reproductive potential, must agree to use FDA approved methods of birth control for the duration of the study
• Children and families have desire to reintroduce potential food allergens and either the food antigen has been recommended with plans for its introduction as part of Standard of Care by the child's allergist and/or gastroenterologist OR the swallowed topical steroid therapy has been recommended to be discontinued by the child's allergist and/or gastroenterologist.
• Children and families willing to undergo unsedated serial TNE

You may not qualify if:

• Inability or unwillingness of a participant to give written informed consent or comply with study protocol
• Bleeding disorder
• Unwilling to undergo unsedated TNE
• Unwilling or unable to come to hospital at least 3 times over 6 weeks.
• Currently treated with a swallowed corticosteroid which is not being discontinued.
• Treated with oral corticosteroids within 8 weeks of the start of the study.
• More than one change is being made to the EoE treatment regimen (e.g., more than a single food is being reintroduced during the study period; the swallowed topical steroid is being discontinued at the same time a food is being introduced).
• EoE has been symptomatic with clinically significant symptoms attributable to EoE including dysphagia, abdominal pain or vomiting in the period since endoscopy
• The finding of uncontrolled cough, significant rhinorrhea or rhinitis obstructing nasal passages, oxygen saturations \<92% (high altitude normal saturation), temperature \>38 degrees Celsius, significant gastrointestinal illness within 1 week of TNE, or provider determination of significant illness during pre-procedure history and physical on the day that the TNE is planned.
• Pregnancy, breast feeding or plans to become pregnant
• Unable to complete study procedures including endoscopy.
• Allergy to any material or medicine used for procedures
• Use of investigational drugs within 16 weeks of participation
• 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

• Children's Hospital Medical Center, Cincinnati: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Office of Rare Diseases (ORD): collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Children's Hospital Colorado

Denver, Colorado, 80218, United States

Location

Related Links

• Related info

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

• Joel Friedlander, M.D.

  Children's Hospital Colorado

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 17, 2017
• Study Start: October 1, 2017
• Primary Completion: August 31, 2020
• Study Completion: September 1, 2020
• Last Updated: March 9, 2021

Record last verified: 2021-03

Locations

US (1)