Application of a Novel Allergen-Specific Immune Signature Directed Approach to Dietary Elimination Therapy in Patients With Eosinophilic Esophagitis (IDiET)

NCT02722148 | Completed Results

• 1 other identifier: 15-2719
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective single center clinical trial of allergen-specific immune signature-guided dietary elimination therapy to assess the clinical effectiveness of this technique.

Conditions

Eosinophilic Esophagitis

Keywords

Eosinophilic Esophagitis; Diet Elimination Therapy

Outcome Measures

Primary Outcomes (1)

• Percentage of Histologic Responders

  The primary outcome will be histologic response, defined as a post-treatment esophageal eosinophil count of \<15 eos/hpf.

  6 Weeks

Secondary Outcomes (3)

• Median Peak Esophageal Eosinophil Count

  6 Weeks

• Endoscopy Score

  6 Weeks

• Dysphagia Symptom Score

  6 Weeks

Study Arms (1)

Enrolled Patients

EXPERIMENTAL

All enrolled subjects will receive a novel allergen-specific immune signature directed approach to dietary elimination therapy

Device: Novel Allergen-Specific Immune Signature Directed Approach to Dietary Elimination Therapy

Interventions

Novel Allergen-Specific Immune Signature Directed Approach to Dietary Elimination Therapy DEVICE

A novel assay developed by the investigator to diagnose food allergens. Results from the assay are used to guide food elimination therapy for the treatment of Eosinophilic Esophagitis (EoE).

Enrolled Patients

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 16-80 years old
• Meet one of the following:
• Active EoE as per consensus guidelines OR
• Undergoing upper endoscopy for a clinical suspicion of EoE
• No prior history of dietary elimination therapy

You may not qualify if:

• Concomitant eosinophilic gastroenteritis
• Any corticosteroid exposure in the 4 weeks prior to their baseline endoscopic exam
• Previous esophageal surgery
• Medical instability that precludes safely performing upper endoscopy
• Inability to read or understand English
• Pregnant women

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

UNC Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• Dellon ES, Guo R, McGee SJ, Hamilton DK, Nicolai E, Covington J, Moist SE, Arrington A, Wright BL, Burks AW, Vickery BP, Kulis M. A Novel Allergen-Specific Immune Signature-Directed Approach to Dietary Elimination in Eosinophilic Esophagitis. Clin Transl Gastroenterol. 2019 Dec;10(12):e00099. doi: 10.14309/ctg.0000000000000099.

  PMID: 31789931 DERIVED

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

Results Point of Contact

• Title: Dr. Evan S. Dellon
• Organization: University of North Carolina at Chapel Hill

evan_dellon@med.unc.edu

(919) 966-2513

Study Officials

• Evan S Dellon, MD, MPH

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

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: March 24, 2016
• First Posted: March 29, 2016
• Study Start: April 21, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: April 2, 2019
• Results First Posted: April 2, 2019

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)