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

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

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

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.

Detailed 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.

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 wi
Sponsor: University of North Carolina, Chapel Hill

Current Primary Outcome: Histologic response (eosinophil counts at baseline and 6 weeks) [ Time Frame: Baseline and 6 Weeks ]

The primary outcome will be histologic response, defined as a post-treatment esophageal eosinophil count of <15 eos/hpf. The esophageal eosinophil counts will be quantified using our previously validated protocol.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Absolute esophageal eosinophil count [ Time Frame: Baseline and 6 Weeks ]
    Change in the absolute esophageal eosinophil count
  • Endoscopy score [ Time Frame: Baseline and 6 Weeks ]
    Improvement in the endoscopic appearance, as measured by a validated endoscopy score
  • Dysphagia symptom score [ Time Frame: Baseline and 6 Weeks ]
    Improvement in symptoms, as measured by a validated dysphagia symptom score


Original Secondary Outcome: Same as current

Information By: University of North Carolina, Chapel Hill

Dates:
Date Received: March 24, 2016
Date Started: March 2016
Date Completion: May 2018
Last Updated: May 15, 2017
Last Verified: May 2017