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

NCT07012928 | Recruiting

• 2 other identifiers: 2024.0849Sanofi
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Eosinophilic Esophagitis (EoE)

Keywords

Eosinophilic Esophagitis; Dupilumab; Permeability esophagus; TEER

Outcome Measures

Primary Outcomes (1)

• Local clinical and immunological responses in eosinophilic esophagitis (EoE) patients, role of mucosal barrier function and type II inflammation

  Esophagael barrier function improvement after 26 week of dupilumab treatment in EoE patients, assessed by the change in transepithelial electrical resistance (TEER).

  26 weeks after dupilumab

Secondary Outcomes (1)

• Food-induced immune responses in EoE patients after dupilumab

  26 weeks after dupilumab

Study Arms (3)

Dupilumab

Blood, biopsies, questionnaire

Active EoE disease

Blood, biopsies, questionnaire

Control

Blood, biopsies

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Most of the patients will have active EoE at the beginning, 12 will be treated with dupilumab, 20 active disease patients. There will be 12 patients without EoE

You may qualify if:

• EoE patient group with dupilumab or topical budesonide Previous diagnosis of active EoE confirmed by histopathology e.g. presence of 15 or more eosinophilic granulocytes per hpf in mid or proximal esophageal biopsies Scheduled to start with dupilumab or topical budesonide as regular care 18 to 75 years of age Written informed consent must be obtained and documented
• EoE patient group with active EoE Previous diagnosis of active EoE confirmed by histopathology e.g. presence of 15 or more eosinophilic granulocytes per hpf in mid or proximal esophageal biopsies Scheduled for an upper endoscopy 18 to 75 years of age Written informed consent must be obtained and documented
• Non-EoE control group Scheduled for a upper endoscopy for other, non-esophageal related, symptoms 18 to 75 years of age Written informed consent must be obtained and documented

You may not qualify if:

• EoE patient group with dupilumab, topical budesonide and with active EoE Use of oral or systemic antihistaminics, oral cromoglicates, systemic corticosteroids, leukotriene inhibitors or monoclonal antibodies, in the month preceding the study Proven gastroesophageal reflux disease or other cause for esophageal eosinophilia, History of peptic ulcer disease, History of Barrett's esophagus, History of gastro intestinal cancer or ASA class III, IV or V
• Non-EoE control group Symptoms suggestive of esophageal disease or other disease that may infolve the esophagus Personal history of atopic, skin or systemic diseases

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam UMC

Amsterdam, North Holland, 1081HV, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and esophagus biopsies

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

Central Study Contacts

Mandy Fijnenberg, WO medicine

CONTACT

+316 55946709; m.fijnenberg@amsterdamumc.nl

Albert J. Bredenoord, gastroenterologist

CONTACT

a.j.bredenoord@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: June 10, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: June 10, 2025

Record last verified: 2025-05

Locations

NL (1)