The Potential Role of Compounds Derived From Ultra-processed Foods in Pathogenesis of Eosinophilic Esophagitis

NCT ID: NCT06093204

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-12
• Study Completion Date: 2026-06-12

Brief Summary

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.

Conditions

Esophagitis, Eosinophilic

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with eosinophilic esophagitis

Patients with a sure diagnosis of eosinophilic esophagitis

Dietary evaluation

Intervention Type: OTHER

Comparative evaluation of the dietary consumption of ultraprocessed foods and ultraprocessed foods-derived compounds

Sex and age matched healthy controls

Matched healthy controls for age and gender, without eosinophilic esophagitis

Dietary evaluation

Intervention Type: OTHER

Comparative evaluation of the dietary consumption of ultraprocessed foods and ultraprocessed foods-derived compounds

Interventions

Dietary evaluation

Comparative evaluation of the dietary consumption of ultraprocessed foods and ultraprocessed foods-derived compounds

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• both sexes
• age between 3-65 years
• sure diagnosis of eosinophilic esophagitis
• age- and sex-matched healthy controls
• parents/tutor written informed consent.

Exclusion Criteria

• lack of written informed consent;
• non-Caucasian ethnicity
• age at enrollment < 3 or >65 years
• simultaneous presence of other chronic diseases: eosinophilic gastroenteritis, eosinophilic colitis, achalasia, GERD, hypereosinophilia syndrome, IBD, fungal or viral infections, connective tissue disorders, autoimmune diseases, vasculitis, bullous dermatosis with oesophageal involvement (pemphigus), drug hypersensitivity reactions, drug-induced oesophagitis, graft vs host disease, monogenic disorders (Marfan syndrome type 2, HIES, PTEN).
• presence of tattoos, scars, moles or particular lesions on both forearms

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Roberto Berni Canani, MD, PhD

MD,PhD,Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Traslational Medical Science - University of Naples Federico II

Naples, , Italy

Site Status: RECRUITING

Department of Traslational Medical Science - University of Naples Federico II

Naples, , Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Roberto Berni Canani, MD, PhD

Role: primary

berni@unina.it

0817462680

Roberto Berni Canani

Role: primary

berni@unina.it

0817462680

Other Identifiers

00014834

Identifier Type: -

Identifier Source: org_study_id