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Esophagitis, EosinophilicNCT06093204

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

An observational study of Esophagitis, Eosinophilic, run by Federico II University at 2 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 3 to 65 years
Conditions the study is for
Esophagitis, Eosinophilic
What is being tested?
Dietary evaluation
How many people
100 participants
Where
2 sitesItaly
Study dates
12 Apr 2023to 12 Jun 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Italy2 sites, 2 recruiting
  • Department of Traslational Medical Science - University of Naples Federico II

    Naples, Naples, 80131

    Roberto Berni Canani, MD, PhD, 0817462680, berni@unina.it

    Recruiting
  • Department of Traslational Medical Science - University of Naples Federico II

    Naples, Naples, 80131

    Roberto Berni Canani, 0817462680, berni@unina.it

    Recruiting

Other trials in Italy

About this study

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.

Read more

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.

Being tested
Dietary evaluation
Medical subject headings
Eosinophilic Esophagitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dietary evaluationOther

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

Study groups in NCT06093204
Study groupRoleWhat they receive
Patients with eosinophilic esophagitisPatients with a sure diagnosis of eosinophilic esophagitis
Receives: Other: Dietary evaluation
Sex and age matched healthy controlsMatched healthy controls for age and gender, without eosinophilic esophagitis
Receives: Other: Dietary evaluation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparative evaluation of the dietary consumption of Ultraprocessed Foods

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

    Measured: At enrollment

Secondary outcomes (8)
  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.

    Measured: 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).

    Measured: At enrollment

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

    ELISA test.

    Measured: At enrollment

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

    ELISA test

    Measured: At enrollment

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

    flow cytometry

    Measured: At enrollment

  6. Disease severity

    Pediatric Eosinophilic Esophagitis Symptom Scores (PEES Score)

    Measured: At 3 months, at 6 months

  7. Disease severity

    Eosinophilic Esophagitis Endoscopic Reference Score (EREFS Score)

    Measured: 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)

    Measured: At 3 months, at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2023
  2. Study start12 Apr 2023
  3. Primary completion12 Jun 2025
  4. Study completion12 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06093204
Sponsor's protocol ID
00014834
Status last verified
Jul 2026
First submitted
26 Jul 2023
Last updated
1 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Esophagitis, Eosinophilic, run by Federico II University at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparative evaluation of the dietary consumption of Ultraprocessed Foods (time frame: At enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.

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