Local immune and barrier changes in eosinophilic esophagitis
Local Clinical and Immunological Responses in Eosinophilic Esophagitis (EoE) Patients, Role of Mucosal Barrier Function and Type II Inflammation
This study tests whether esophageal barrier problems and type 2 inflammation differ in adults with EoE (including those starting dupilumab or topical budesonide) compared with people without EoE.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 56 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Drugs / interventions | dupilumab |
| Locations | 1 site (Amsterdam, North Holland) |
| Trial ID | NCT07012928 on ClinicalTrials.gov |
What this trial studies
This observational study will enroll adults with active EoE—some who are starting dupilumab or topical budesonide—and non‑EoE controls undergoing upper endoscopy. Researchers will collect esophageal biopsies and measure mucosal barrier function (including transepithelial electrical resistance/TEER and permeability), histology, and local immune markers of type 2 inflammation. In the treatment subgroup, samples will be compared before and during routine therapy to describe local immunological and barrier changes over time. The work aims to clarify local responses that may explain how food triggers start inflammation and why some therapies do not fully restore barrier integrity.
Who should consider this trial
Good fit: Ideal candidates are adults 18–75 with histologically confirmed active EoE who are either scheduled to start dupilumab or topical budesonide or are scheduled for an upper endoscopy, plus non‑EoE adults undergoing endoscopy as controls.
Not a fit: Patients unlikely to receive benefit include those not eligible for or unwilling to undergo endoscopy, children under 18, people on systemic immunosuppressive therapy or with other active esophageal diseases, and individuals unable to travel to the study center.
Why it matters
Potential benefit: If successful, the findings could identify local biomarkers or mechanisms to help predict who will benefit from targeted therapies and guide more personalized treatment to reduce esophageal inflammation and food impaction.
How similar studies have performed: Previous trials show topical steroids and dupilumab reduce esophageal eosinophilia and symptoms and steroids partially improve barrier function, but early local immune responses after food challenge and full barrier restoration remain incompletely studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Where this trial is running
Amsterdam, North Holland
- Amsterdam UMC — Amsterdam, North Holland, Netherlands (Recruiting)
Study contacts
- Study coordinator: Mandy Fijnenberg, WO medicine
- Email: m.fijnenberg@amsterdamumc.nl
- Phone: +316 55946709
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.