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

• ClinicalTrials.gov Identifier: NCT02722148
• Recruitment Status: Completed
• First Posted: March 29, 2016
• Results First Posted: April 2, 2019
• Last Update Posted: April 2, 2019
• Sponsor: University of North Carolina, Chapel Hill
• Collaborator: National Institutes of Health (NIH)
• Information provided by (Responsible Party): University of North Carolina, Chapel Hill

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Eosinophilic Esophagitis	Device: Novel Allergen-Specific Immune Signature Directed Approach to Dietary Elimination Therapy	Not Applicable

Detailed Description:

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.

Potential subjects will be approached regarding the study. If eligible and interested, then informed consent will be obtained and they will be enrolled in the study. If the subject as had an esophagogastroduodenoscopy (EGD) at UNC with 3 month since enrollment, clinical biopsies from the EGD show active EoE and the subject continues to meet consensus guidelines for active EoE, and research biopsies were taken during that EGD that can be used for this study, then the subject will complete questionnaires and a blood draw only. The blood draw may be abbreviated if the subject had research blood drawn during the same recent EGD that can be used in this study.

If subjects have not had an EGD with biopsies at UNC within 3 months prior to enrollment, then they will complete questionnaires, a blood draw, and be scheduled to receive a routine care esophagogastroduodenoscopy (EGD) at UNC facilities with clinical and research biopsies. However, in some cases, samples that were obtained prior to this time frame can be used, as long as the samples were obtained when the EoE was active and there were no major changes in clinical status.

During the routine care endoscopy, clinical biopsies will be taken for routine care purposes, and additional research biopsies will be collected for research purposes for diet elimination testing and to be stored for future research studies from the distal, mid, and proximal esophagus. Blood will also be collected during this visit, and questionnaires completed. If research biopsies are unable to be obtained during this EGD the subject will no longer continue in the study and will be considered a screen fail. If pathology from routine care biopsies does not confirm a diagnosis of active EoE, then the subject will no longer continue in the study and will be considered a screen fail. If subjects have had an EGD with clinical and research biopsies within 3 months prior to enrollment, then research biopsies taken during that EGD will be used for this study. As noted above, in some cases, samples that were obtained prior to this time frame can be used, as long as the samples were obtained when the EoE was active and there were no major changes in clinical status.

After completion of the EGD (or collection of EGD records and previous biopsies if an EGD was previously completed), and confirmation of eligibility, subjects will be scheduled for a routine care nutrition counseling appointment. Two weeks prior to the routine care nutrition counseling appointment, subject will begin the dysphagia symptom questionnaire (DSQ). During the routine care nutrition counseling appointment, the subject will receive counseling on which foods to eliminate based on the novel assay results from the research biopsies. Subjects will also receive an allergy skin test during this visit. Results from the allergy skin test will not be used to drive food elimination diet.

Subjects will follow their assigned food elimination diet for 6 weeks. At 6 weeks subjects will be scheduled for a routine care esophagogastroduodenoscopy (EGD) with biopsies for clinical purposes. Two weeks prior to the 6 week EGD subjects will restart the DSQ. Data will be collected from the 6 week EGD but no research specific biopsies will be obtained during that visit. Research specific blood will be taken at this visit. Study participation is complete after completion of the 6 week EGD.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Application of a Novel Allergen-Specific Immune Signature Directed Approach to Dietary Elimination Therapy in Patients With Eosinophilic Esophagitis (IDiET)
• Actual Study Start Date: April 21, 2016
• Actual Primary Completion Date: April 2018
• Actual Study Completion Date: April 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Enrolled Patients; 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; 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).

Outcome Measures

Primary Outcome Measures :

1. Percentage of Histologic Responders [ Time Frame: 6 Weeks ]
   The primary outcome will be histologic response, defined as a post-treatment esophageal eosinophil count of <15 eos/hpf.

Secondary Outcome Measures :

1. Median Peak Esophageal Eosinophil Count [ Time Frame: 6 Weeks ]
   Eosinophil count per High Power Field
2. Endoscopy Score [ Time Frame: 6 Weeks ]
   Post treatment endoscopic appearance, as measured by a validated endoscopy score - the EoE Endoscopic Reference Score (EREFS). This score measures endoscopic severity with a set of five endoscopic findings (exudates, rings, edema, furrows, and strictures), and ranges from 0-9, with higher scores indicating higher endoscopic severity.
3. Dysphagia Symptom Score [ Time Frame: 6 Weeks ]
   Post treatment symptoms, as measured by a validated dysphagia symptom score, the EoE Symptom Activity Index (EEsAI). This score ranges from 0-100, with higher scores indicating more severe symptoms. A score of < 20 indicates clinical remission.

Eligibility Criteria

• Ages Eligible for Study: 16 Years to 80 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Age 16-80 years old

2. Meet one of the following:

   1. Active EoE as per consensus guidelines OR
   2. Undergoing upper endoscopy for a clinical suspicion of EoE
3. No prior history of dietary elimination therapy

Exclusion Criteria:

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

Contacts and Locations

Locations

United States, North Carolina

UNC Chapel Hill

Chapel Hill, North Carolina, United States, 27599

Sponsors and Collaborators

University of North Carolina, Chapel Hill

National Institutes of Health (NIH)

Investigators

• Principal Investigator: Evan S Dellon, MD, MPH; UNC Chapel Hill

  Study Documents (Full-Text)

Documents provided by University of North Carolina, Chapel Hill:

Study Protocol and Statistical Analysis Plan  [PDF] June 20, 2017

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT02722148
• Other Study ID Numbers: 15-2719
• First Posted: March 29, 2016
• Results First Posted: April 2, 2019
• Last Update Posted: April 2, 2019
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: No plans to share data

• Product Manufactured in and Exported from the U.S.: No

Keywords provided by University of North Carolina, Chapel Hill:

Eosinophilic Esophagitis; Diet Elimination Therapy

Additional relevant MeSH terms:

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