CClinicalTrials.gg
RecruitingNCT06093204Updated Sep 1, 2026

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

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

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
3 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Esophagitis, Eosinophilic
03

Who can participate

Ages eligible
3 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

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

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
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherDietary evaluation

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

05

What researchers measure

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.

    Time frame: At enrollment

Secondary outcomes

  1. 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

  2. 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

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

    ELISA test.

    Time frame: At enrollment

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

    ELISA test

    Time frame: At enrollment

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

    flow cytometry

    Time frame: At enrollment

  6. Disease severity

    Pediatric Eosinophilic Esophagitis Symptom Scores (PEES Score)

    Time frame: At 3 months, at 6 months

  7. Disease severity

    Eosinophilic Esophagitis Endoscopic Reference Score (EREFS Score)

    Time frame: At 3 months, at 6 months

  8. 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

06

Study locations

2 of 2 sites recruiting
  • Department of Traslational Medical Science - University of Naples Federico II
    Naples, Naples 80131, Italy
    • Roberto Berni Canani, MD, PhD · Contact · berni@unina.it · 0817462680
    Recruiting
  • Department of Traslational Medical Science - University of Naples Federico II
    Naples, Naples 80131, Italy
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06093204
Lead sponsor
Federico II University
Responsible party
Roberto Berni Canani, MD, PhD (MD,PhD,Prof., Federico II University) — Principal investigator
First posted
Oct 23, 2023
Start date
Apr 12, 2023
Primary completion
Jun 12, 2025
Completion
Jun 12, 2027 (estimated)
Last update
Sep 1, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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