New Clinical Trial for Eosinophilic Esophagitis is Now Recruiting Participants

Eosinophilic Esophagitis (EoE)

Eosinophilic esophagitis (EoE) is a rare and chronic disorder which affects the digestive system.

Eosinophils are a type of white blood cell that help fight infections. This means that when there is a large accumulation of these cells, a disease is likely present. In EoE a large amount of these cells are present in the esophagus.

EoE is either caused by an immune hypersensitivity to a certain food or to an environmental allergen. However, some patients have high expressions of the eotaxin-3 gene which suggests that the condition could also have a genetic component.

Symptoms of EoE are dysphagia, nausea, stomach pain, weight loss, poor appetite, and malnutrition among others. Many patients also have another allergy disease like eczema or asthma.

There is much about this condition that is still not understood. Some patients are able to improve their condition simply by modifying their diet (for instance, eliminating milk, soy, nuts, wheat, and eggs). Others patients require a liquid feeding formula. In addition to diet modifications, some patients also require steroid medications which help to control inflammation.

Researchers are currently investigating medications that would target the proteins that this condition produces. This treatment could be efficacious for patients who have the eotaxin-3 gene.

In addition to this research, scientists at the University of California, San Diego (UCSD), in collaboration with the NIH and the NIAID, are working to understand more of the natural history of this disease as well as its inflammatory markers through a new observational clinical trial.

Clinical Trial

The trial was first posted on ClinicalTrials.gov on June 10, 2019. It is being conducted solely at UCSD. The official title of this investigation is “Characteristics and Inflammatory Markers in Children with Eosinophilic Esophagitis.” The trial was initiated on December 17, 2018 and it is estimated that it will be completed by December 17, 2028.

This ongoing investigation is currently recruiting patients. Researchers estimate they will enroll 1,200 patients. Individuals are being recruited during routine clinic/endoscopy visits at Rady Children’s Hospital.

The data collected from this investigation will be entered into the UCSD database. This database will then become more and more valuable as more information is added to it, tracking disease progression, therapeutic response, and natural history. Databases like such are especially valuable for patients who have varying disease phenotypes. It will also assist researchers in the analysis of associations between molecular changes, clinical phenotypes, as well as disease course.

People of all sexes are eligible to participate however patients must be between the ages of 1 and 65 years old. Other criteria include:

  • EoE diagnosis
  • Dysphagia, abdominal pain, or vomiting symptoms
  • Esophageal stricture
  • Food impaction
  • Pallor, concentric rings, linear furrows, white plaques, or lichenification

Researchers have indicated that de-identified information as well as patient samples may be shared with other scientists to help facilitate research investigations for the disease.

The primary outcome measures are:

  1. Longitudinal trajectory of endoscopy, symptoms, histology
  2. Longitudinal trajectory of blood and biopsy inflammatory markers

Each primary outcome will be measured over the period of 10 years during routine clinical care visits.

You can find out more about this trial by searching the identifier NCT03980886 or clicking here.


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