An observational study in Food Allergy in Children, sponsored by Federico II University. Recruiting at 1 site in Italy. Open to participants aged 4 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Federico II University · Observational
Non-specific lipid transfer proteins (nsLTPs) are currently recognized as the most prevalent cause of primary IgE-mediated food allergy in Mediterranean populations and constitute a leading trigger of anaphylactic reactions. In Italy, the prevalence of LTP sensitization is estimated at 2-2.4% in adults and approximately 9% in children, with marked geographic variation. Specifically, higher prevalence rates are observed in central and southern regions and on the islands (21.3%-27.2%) compared to the northern regions (approximately 11%).
LTPs are ubiquitous panallergens, widely expressed throughout the plant kingdom. They represent the major allergens within the Rosaceae family in individuals not sensitized to birch pollen and have also been identified and characterized in numerous plant-derived foods, including nuts, legumes, rice, maize, beer, spelt, and wheat. The clinical spectrum of LTP hypersensitivity is highly heterogeneous. While a significant proportion of sensitized individuals remain asymptomatic, others may present with localized reactions such as contact urticaria or oral allergy syndrome (OAS). More severe cases may involve gastrointestinal symptoms (e.g., vomiting, epigastric discomfort, abdominal pain), cutaneous and respiratory manifestations, and systemic responses up to anaphylactic shock.
Nickel is a ubiquitous metal employed in a wide range of industrial applications and consumer products, including stainless steel, metal plating, various alloys, and inexpensive jewelry. It is also naturally present in both animal and plant-based food sources (e.g., cereals, cocoa, legumes, fresh fruits and nuts, fish). Nickel is the most common sensitizer in allergic contact dermatitis, affecting approximately 20% of the general population and around 10% of the pediatric population. Sensitization to nickel involves a delayed-type (Type IV) hypersensitivity reaction and is not IgE-mediated. Clinical manifestations range from localized allergic contact dermatitis to systemic involvement, referred to as systemic nickel allergy syndrome (SNAS), which is characterized predominantly by gastrointestinal symptoms, although respiratory and other systemic manifestations can also occur.
Gastrointestinal symptoms such as gastroesophageal reflux disease (GERD), functional dyspepsia, abdominal pain, and altered bowel habits, when not associated with overt allergic signs or underlying organic disease, are typically classified as functional gastrointestinal disorders (FGIDs). Several studies report that up to 40% of adult patients with FGIDs exhibit nickel sensitization; however, data in the pediatric population remain scarce.
Chelanik® is a dietary supplement designed to support individuals with nickel hypersensitivity. It contains bioactive components purported to exert immunomodulatory and anti-inflammatory effects. Nevertheless, in vitro human data directly demonstrating its activity on lymphocyte function are currently lacking.
This prospective, experimental, single-center study aims to determine the prevalence of sensitization to LTP and nickel among patients presenting with functional dyspepsia or irritable bowel syndrome (IBS), and to assess in vitro the potential immunomodulatory effects of Chelanik® on peripheral blood lymphocytes from individuals with nickel allergy.
376 studies on the registry are indexed under Food Hypersensitivity; 90 are open to participants now.
This study's planned enrollment of 100 is below the median of 151 across 120 observational studies indexed under Food Hypersensitivity.
Browse Food Hypersensitivity studies →Federico II University is the lead sponsor of 366 studies on the registry; 61 are open to participants now.
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50 adults (>18 years) and 50 pediatric (4-17 years), of both sexes, belonging to the Adult Gastroenterology Programs and Pediatrics Section of Department of Translational Medical Sciences (University of Naples Federico II).
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A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Prevalence of nickel and LTP sensitization in patients with symptoms of functional dyspepsia and irritable bowel syndrome
To evaluate the prevalence of nickel and LTP sensitization in patients with symptoms of functional dyspepsia (according to the Rome IV criteria, at least one symptom among the following for at least 4 days at the month and for at least 2 months before diagnosis - feeling of post-prandial fullness, satiety early epigastralgia or heartburn unrelated to defecation - in the absence of organic disease) and irritable bowel syndrome (according to Rome IV criteria, including all of the following for at least 2 months before diagnosis - abdominal pain for at least 4 days per month associated with one/more of the change in evacuation frequency, change in the shape/appearance of stools, if constipation is noticed pain does not resolve with the resolution of constipation - in the absence of organic disease).
Time frame: At baseline
Diagnostic accuracy of the patch test with peach juice
The atopy patch test is evaluated through visual inspection 48 hours after patch removal, with an optional second reading at 72 hours to detect delayed reactions. The reaction at the application site is assessed based on its intensity and classified according to a semi-quantitative scale: \- +: erythema with infiltration * ++: erythema with a few papules * +++: erythema with numerous or widespread papules * ++++: erythema with vesicles.
Time frame: At baseline
Evaluation of the potential immunomodulatory effect of Chelanik® on blood mononuclear cells: characterization and activation of CD4+ and CD8+ T populations
Flow cytometric analysis For the analysis of phenotypes by multiparametric flow cytometry, the following will be used: Antibody panels: * T cell panel: anti-CD3, anti-CD4, anti-CD8, anti-HLA-DR (anti-CD4, anti-CD8, anti-HLA-DR (anti-CD4, anti-CD8, anti-HLA-DR (anti-CD4, anti-CD4, anti-CD4, anti-CD4, anti-CD4, anti-CD8, anti-HLA-DR (anti T lymphocytes), CD45RA (na.ve lymphocytes), CCR7 (memory T cells) and CD38 (activation). * Th1/Th2/Th17 panel: CD3, CD4, CD8, HLA-DR, CCR4 (Th2-associated marker), CCR6 (Th17), CXCR3 (Th1), and CD38 (activation). * Regulatory T cell panel: CD3, CD4, CCR4 (Treg migration), CD25 (activation) and CD127.
Time frame: At baseline
Evaluation of the potential immunomodulatory effect of Chelanik® on blood mononuclear cells: cytokines production
Cytokine assay by ELISA test Analysis of cytokine expression levels (IL-2, IL-5, IL-13, IL-4, IL-22, IFN-γ, IL-17, TNF-α, IL-10) will be. performed on both serum and supernatants of PBMCs cultures. The concentrations of the individual cytokines will be quantified by ELISA enzyme immunoassay, according to the protocols and recommendations provided by the manufacturer of the kit used.
Time frame: At baseline
Started Jul 2025 (actual). Primary completion is estimated for Jul 2027, 24 months after the start.
Of 42 non-industry observational studies under Food Hypersensitivity, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 250. This study's planned 24 months is below that.
Counting every sponsor, half of 43 studies reached it within 42 months; a quarter within 19 and three quarters within 250.
How these figures are worked out, and which studies are left out of them.
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