Actively Recruiting

Age: 18Years - 75Years
All Genders
Healthy Volunteers
NCT07012928

Local Clinical and Immunological Responses in Eosinophilic Esophagitis (EoE) Patients, Role of Mucosal Barrier Function and Type II Inflammation

Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2025-06-10

56

Participants Needed

1

Research Sites

152 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Eosinophilic esophagitis (EoE) is an allergic inflammation of the esophagus. If not treated properly, inflammation and narrowing of the esophagus can occur. This can eventually lead to food impaction. Food allergens play an important role in the pathogenesis of EoE, as demonstrated by endoscopic and clinical resolution of EoE once the causative food is removed from the diet and exacerbation when the same food is reintroduced Similarly, amino acid-based elemental diets are effective in both adults and children with EoE. However, the exact mechanism by which food allergens can initiate inflammation in EoE is still unknown, as there are limited data on the early local esophageal immune response after challenge with a specific food trigger. Previous research has shown that this can be treated with antacids (PPI) and corticosteroids. This reduces the permeability of the esophagus (which is increased in EoE), but not to the level of healthy individuals. Most likely this is due to a mild underlying allergic inflammation that persists under treatment with the above agents. The idea is that dupilumab inhibits this type II inflammation, which will further reduce the permeability. In addition, the effect of food allergens on esophageal biopsies from both EoE patients and healthy patients will be examined. This will then be compared to the biopsies taken after the use of dupilumab.

CONDITIONS

Official Title

Local Clinical and Immunological Responses in Eosinophilic Esophagitis (EoE) Patients, Role of Mucosal Barrier Function and Type II Inflammation

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Previous diagnosis of active eosinophilic esophagitis confirmed by biopsy with 15 or more eosinophilic granulocytes per high power field
  • Scheduled to start treatment with dupilumab or topical budesonide as regular care
  • Aged between 18 and 75 years
  • Written informed consent obtained and documented
  • Scheduled for upper endoscopy for assessment (active EoE group and non-EoE control group)
  • Non-EoE control group scheduled for upper endoscopy for non-esophageal symptoms
  • All participants must be between 18 and 75 years old
  • Written informed consent obtained and documented
Not Eligible

You will not qualify if you...

  • Use of oral or systemic antihistaminics, oral cromoglicates, systemic corticosteroids, leukotriene inhibitors, or monoclonal antibodies in the month before the study
  • Proven gastroesophageal reflux disease or other cause of esophageal eosinophilia
  • History of peptic ulcer disease
  • History of Barrett's esophagus
  • History of gastrointestinal cancer
  • ASA classification of III, IV, or V
  • For non-EoE controls: symptoms suggesting esophageal disease or other diseases involving the esophagus
  • Personal history of atopic, skin, or systemic diseases

AI-Screening

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Trial Site Locations

Total: 1 location

1

Amsterdam UMC

Amsterdam, North Holland, Netherlands, 1081HV

Actively Recruiting

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Research Team

M

Mandy Fijnenberg, WO medicine

CONTACT

A

Albert J. Bredenoord, gastroenterologist

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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