An observational study in Esophagitis, Eosinophilic, sponsored by Federico II University. Recruiting at 2 sites in Italy. Open to participants aged 3 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Federico II University · Observational
Eosinophilic esophagitis (EoE) is a chronic antigen-mediated inflammatory disease of the esophagus that affects both children and adults. The incidence and prevalence of EoE is rapidly increasing in Western countries with an estimated incidence of 6.6 per 100,000 person-years (95% CI, 3-11.7) in children and 7.7 per 100,000 person-years (95% CI, 1.8-17.8) in adults. Clinically, it is characterized by various symptoms related to esophageal dysfunction, including vomiting, regurgitation, feeding difficulties, epigastric heartburn, dysphagia, or food bolus impaction, and may cause growth retardation. Diagnosis is made on the basis of clinical symptoms and histological evidence of eosinophilic infiltration of the esophagus (at least 15 eosinophils/high power microscope field (eos /hpf), excluding other etiologies of esophageal eosinophilia (gastroesophageal reflux disease, infectious esophagitis, achalasia, celiac disease and Crohn's disease, connective tissue disorders, gra ft versus host disease, drug hypersensitivity and hypereosinophilic syndromes). EoE is primarily characterized by a T helper 2 type inflammation, but the pathogenesis and the immunopathological mechanisms underlying the pathology are not yet fully understood. Recent evidence suggests that in genetically predisposed individuals, interaction with environmental factors (e.g., dietary lifestyle) may play a role in activating several inflammatory pathways and cause EoE.
Ultra-processed foods (UPFs) are food and beverage products resulting from industrial formulations, ready for consumption, typically obtained with five or more ingredients from different manufacturing processes (cooking methods, addition of additives such as stabilizers or preservatives). During the last decade, the consumption of the latter has increased significantly among the pediatric population to represent 30% of the daily caloric intake of an average child in Europe and America. Recent evidences show that UPFs favor the onset of chronic non-communicable diseases through the activation of different inflammatory pathways.
The components mostly represented in UPFs are the advanced glycation end products (AGEs), a heterogeneous group of highly oxidizing compounds that are formed through non-enzymatic reactions (Maillard reaction) between reduced sugars and free amino groups of proteins, lipids, or nucleic acids.
Evidence demonstrates that dietary AGEs are absorbed and contribute significantly to the total concentration of AGEs in the body. AGEs induce oxidative stress and inflammation, leading to structural and functional protein alterations, cellular apoptosis and multi-tissue/organ damage. These mechanisms are mediated at least in part by interactions with their cell-surface receptor for advanced glycation end-products (RAGE).
The AGEs-RAGE interaction modulates the immune response. AGEs are able to activate le mast cells, to stimulate the release of histamine and to induce a chronic inflammatory state that promotes a T helper 2 type response.
235 studies on the registry are indexed under Eosinophilic Esophagitis; 53 are open to participants now.
This study's planned enrollment of 100 is above the median of 88 across 85 observational studies indexed under Eosinophilic Esophagitis.
Browse Eosinophilic Esophagitis studies →Federico II University is the lead sponsor of 366 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients both sexes, aged between 3-65 years with diagnosis of eosinophilic esophagitis and age- and sex-matched healthy controls
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with a sure diagnosis of eosinophilic esophagitis
Other: Dietary evaluation
Matched healthy controls for age and gender, without eosinophilic esophagitis
Other: Dietary evaluation
Comparative evaluation of the dietary consumption of ultraprocessed foods and ultraprocessed foods-derived compounds
Comparative evaluation of the dietary consumption of Ultraprocessed Foods
A 7-day food diary to evaluate the dietary intake of ultraprocessed foods.
Time frame: At enrollment
Intake of dietary Advanced Glycation End-products
A 7-day food diary to evaluate the dietary intake of the detrimental compounds of ultraprocessed foods, the advanced glycation end-products.
Time frame: At enrollment
Skin Advanced Gycation End-products accumulation level
AGEs reader to evaluate the skin Advanced Gycation End-products accumulation level. Skin AGEs levels will be calculated as the ratio between the emission light and reflected excitation light, multiplied by 100 and expressed in arbitrary units (AU).
Time frame: At enrollment
Advanced Glycation End-Products receptor (RAGE) expression in peripheral blood mononuclear cells (PBMCs)
ELISA test.
Time frame: At enrollment
Advanced Glycation End-Products receptor (RAGE) expression in plasma
ELISA test
Time frame: At enrollment
Advanced Glycation End-Products receptor (RAGE) expression in peripheral blood mononuclear cells (PBMCs)
flow cytometry
Time frame: At enrollment
Disease severity
Pediatric Eosinophilic Esophagitis Symptom Scores (PEES Score)
Time frame: At 3 months, at 6 months
Disease severity
Eosinophilic Esophagitis Endoscopic Reference Score (EREFS Score)
Time frame: At 3 months, at 6 months
Treatment response
Drug used for inducing eosinophilic esophagitis remission defined as \<15 eosinophils per high-power field (eos/hpf)
Time frame: At 3 months, at 6 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2023 to primary completion in Jun 2025, 26 months.
Of 52 non-industry observational studies under Eosinophilic Esophagitis, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 120. This study's 26 months is below that.
Counting every sponsor, half of 55 studies reached it within 49 months; a quarter within 22 and three quarters within 120.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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