Study of Nickel and Lipid Transfer Protein Sensitization in Children and Adults with Functional Dyspepsia and Irritable Bowel Syndrome

What this Trial Is About

Researchers are investigating the role of sensitization to non-specific lipid transfer proteins nsLTPs and nickel in people with functional gastrointestinal disorders such as functional dyspepsia and irritable bowel syndrome IBS. These allergens are common in Mediterranean populations and can cause a range of allergic reactions from mild to severe. The study focuses on the prevalence of these sensitizations and explores their connection to gastrointestinal symptoms without an obvious organic cause. This observational study will enroll participants aged 4 to 65 years experiencing symptoms of functional dyspepsia or IBS as defined by specific clinical criteria. The study aims to assess sensitization to nsLTPs and nickel and to evaluate in vitro the potential immunomodulatory effects of a dietary supplement called Chelanik, which contains bioactive components thought to influence immune cells. Blood samples will be collected to study lymphocyte activity and cytokine production. Participants will undergo baseline evaluations including tests for nickel and nsLTP sensitization and immune cell analysis before any intervention. The main outcome measured is the prevalence of these sensitizations among participants. Researchers will also assess diagnostic accuracy of a patch test with peach juice and the immunomodulatory potential of Chelanik on blood mononuclear cells. The study will provide insights into how these allergens may relate to gastrointestinal symptoms and immune function over the course of participation.

The Role of NIchel and LTPs Sensitization in Functional Gastrointestinal Disorders: the NILT Study