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

NCT06093204 | Recruiting

• 1 other identifier: 00014834
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Comparative evaluation of the dietary consumption of Ultraprocessed Foods

  A 7-day food diary to evaluate the dietary intake of ultraprocessed foods.

  At enrollment

Secondary Outcomes (8)

• Intake of dietary Advanced Glycation End-products

  At enrollment

• Skin Advanced Gycation End-products accumulation level

  At enrollment

• Advanced Glycation End-Products receptor (RAGE) expression in peripheral blood mononuclear cells (PBMCs)

  At enrollment

• Advanced Glycation End-Products receptor (RAGE) expression in plasma

  At enrollment

• Advanced Glycation End-Products receptor (RAGE) expression in peripheral blood mononuclear cells (PBMCs)

  At enrollment

Study Arms (2)

Patients with eosinophilic esophagitis

Patients with a sure diagnosis of eosinophilic esophagitis

Other: Dietary evaluation

Sex and age matched healthy controls

Matched healthy controls for age and gender, without eosinophilic esophagitis

Other: Dietary evaluation

Interventions

Dietary evaluation OTHER

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

Patients with eosinophilic esophagitis; Sex and age matched healthy controls

Eligibility Criteria

• Age: 3 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients both sexes, aged between 3-65 years with diagnosis of eosinophilic esophagitis and age- and sex-matched healthy controls

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (2)

Department of Traslational Medical Science - University of Naples Federico II

Naples, 80131, Italy

RECRUITING

Department of Traslational Medical Science - University of Naples Federico II

Naples, 80131, Italy

RECRUITING

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD,Prof.

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: October 23, 2023
• Study Start: April 12, 2023
• Primary Completion: June 12, 2025
• Study Completion (Estimated): June 12, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)