Actively Recruiting
The Role of Nickel and nsLTP Sensitization in Functional Gastrointestinal Disorders: the NILT Study
Led by Federico II University · Updated on 2025-08-06
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
The Role of NIchel and LTPs Sensitization in Functional Gastrointestinal Disorders: the NILT Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age at least of 4 years
- Both sexes
- History of functional dyspepsia according to Rome IV criteria with symptoms lasting more than 2 months
- History of irritable bowel syndrome according to Rome IV criteria with abdominal pain for at least 4 days per month for at least 2 months
- Written informed consent from parents and participants over 6 years old
You will not qualify if you...
- Age less than 4 years
- Evidence of organic gastrointestinal diseases such as GERD, Helicobacter Pylori infection, eosinophilic diseases, celiac disease, chronic inflammatory bowel disease, chronic pancreatitis, cholelithiasis, or neoplasia
- Post-infectious motility disorders
- Food intolerances like lactose intolerance or carbohydrate malabsorption
- Use of aspirin (ASAs) or NSAIDs
- Chronic systemic diseases including diabetes, amyloidosis, neuropathy, and autoimmune diseases
- Neuropsychiatric disorders
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At baseline
Participants undergo diagnostic assessments to evaluate nickel and nsLTP sensitization and related immune responses.
1 visit (in-person)
Duration - Up to study completion in July 2027
Participants are observed for the prevalence and progression of sensitization and symptoms related to functional gastrointestinal disorders.
Follow-up visits as scheduled by the study team
Trial Site Locations
Total: 1 location
1
Department of Traslational Medical Science - University of Naples Federico II
Naples, Italy, 80131
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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