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

Sponsor
Federico II University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06093204
Collaborator
(none)
80
2
24
40
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Dietary evaluation

Study Design

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
The Potential Role of Compounds Derived From Ultra-processed Foods in Pathogenesis of Eosinophilic Esophagitis
Actual Study Start Date :
Apr 12, 2023
Anticipated Primary Completion Date :
Apr 12, 2025
Anticipated Study Completion Date :
Apr 12, 2025

Arms and Interventions

Arm Intervention/Treatment
Patients with eosinophilic esophagitis

Pediatric patients with a sure diagnosis of eosinophilic esophagitis

Other: Dietary evaluation
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

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

Outcome Measures

Primary Outcome Measures

  1. Comparative evaluation of the dietary consumption of Ultraprocessed Foods [At enrollment]

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

Secondary Outcome Measures

  1. Intake of dietary Advanced Glycation End-products [At enrollment]

    A 7-day food diary to evaluate the dietary intake of the detrimental compounds of ultraprocessed foods, the advanced glycation end-products.

  2. Skin Advanced Gycation End-products accumulation level [At enrollment]

    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).

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

    ELISA test.

  4. Advanced Glycation End-Products receptor (RAGE) expression in plasma [At enrollment]

    ELISA test

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

    flow cytometry

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • both sexes

  • age between 10-18 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 < 10 or >18 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Traslational Medical Science - University of Naples Federico II Naples Italy 80131
2 Department of Traslational Medical Science - University of Naples Federico II Naples Italy 80131

Sponsors and Collaborators

  • Federico II University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Roberto Berni Canani, MD, PhD, MD,PhD,Prof., Federico II University
ClinicalTrials.gov Identifier:
NCT06093204
Other Study ID Numbers:
  • 00014834
First Posted:
Oct 23, 2023
Last Update Posted:
Oct 23, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 23, 2023