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.
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
- 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
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.
- Conditions
- Esophagitis, Eosinophilic
- 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 group | Role | What they receive |
|---|---|---|
| Patients with eosinophilic esophagitis | Patients with a sure diagnosis of eosinophilic esophagitis Receives: Other: Dietary evaluation | |
| Sex and age matched healthy controls | Matched 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.
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)
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
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
Advanced Glycation End-Products receptor (RAGE) expression in peripheral blood mononuclear cells (PBMCs)
ELISA test.
Measured: At enrollment
Advanced Glycation End-Products receptor (RAGE) expression in plasma
ELISA test
Measured: At enrollment
Advanced Glycation End-Products receptor (RAGE) expression in peripheral blood mononuclear cells (PBMCs)
flow cytometry
Measured: At enrollment
Disease severity
Pediatric Eosinophilic Esophagitis Symptom Scores (PEES Score)
Measured: At 3 months, at 6 months
Disease severity
Eosinophilic Esophagitis Endoscopic Reference Score (EREFS Score)
Measured: At 3 months, at 6 months
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.
- First posted23 Oct 2023
- Study start12 Apr 2023
- Primary completion12 Jun 2025
- Study completion12 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagitis, EosinophilicStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Berni Canani, MD, PhD, Federico II University
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential Role of Compounds Derived From Ultra-processed Foods in Pathogenesis of Eosinophilic Esophagitis
- ClinicalTrials.gov ID
- NCT06093204
- Acronym / sponsor ID
- 00014834
- Conditions
- Esophagitis, Eosinophilic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 12 Jun 2025 (actual)
- Study completion
- 12 Jun 2027 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with eosinophilic esophagitis | – | Other: Dietary evaluationPatients with a sure diagnosis of eosinophilic esophagitis |
| Sex and age matched healthy controls | – | Other: Dietary evaluationMatched healthy controls for age and gender, without eosinophilic esophagitis |
Who may qualify
- Ages
- 3 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (5 listed)
- both sexes
- age between 3-65 years
- sure diagnosis of eosinophilic esophagitis
- age- and sex-matched healthy controls
- parents/tutor written informed consent.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary evaluationComparative evaluation of the dietary consumption of ultraprocessed foods and ultraprocessed foods-derived compounds | Other | Patients with eosinophilic esophagitis, Sex and age matched healthy controls |
Primary outcome
Comparative evaluation of the dietary consumption of Ultraprocessed Foods
Time frame: At enrollment
A 7-day food diary to evaluate the dietary intake of ultraprocessed foods.
8 secondary outcomes
Intake of dietary Advanced Glycation End-products
Time frame: At enrollment
Skin Advanced Gycation End-products accumulation level
Time frame: At enrollment
Advanced Glycation End-Products receptor (RAGE) expression in peripheral blood mononuclear cells (PBMCs)
Time frame: At enrollment
Advanced Glycation End-Products receptor (RAGE) expression in plasma
Time frame: At enrollment
Advanced Glycation End-Products receptor (RAGE) expression in peripheral blood mononuclear cells (PBMCs)
Time frame: At enrollment
Disease severity
Time frame: At 3 months, at 6 months
Disease severity
Time frame: At 3 months, at 6 months
Treatment response
Time frame: At 3 months, at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Department of Traslational Medical Science - University of Naples Federico II
Naples, Italy
Department of Traslational Medical Science - University of Naples Federico II
Naples, Italy
2 sites in 1 country: see every site and its status.
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.