Nickel and LTP sensitization in children with functional gastrointestinal disorders
Official title: The Role of NIchel and LTPs Sensitization in Functional Gastrointestinal Disorders: the NILT Study
Run by Federico II University · NCT07105865 · Data updated 2026-11-12
This research tests whether sensitization to non-specific lipid transfer proteins (LTPs) and to nickel is linked to functional gut symptoms in children aged 4 and older with dyspepsia or irritable bowel symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 4 Years to 65 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Federico II University Academic / other |
| Locations | 1 site (Naples, Naples) |
| Status | Recruiting |
| Started | July 1, 2025 |
| Main results expected | July 1, 2027 |
| Study ends | July 1, 2027 |
| Registry record updated | September 1, 2026 |
| Trial ID | NCT07105865 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 4 years and older with functional dyspepsia or irritable bowel syndrome by Rome IV criteria and parental (and participant, if applicable) informed consent are the ideal candidates.
✕Probably not a fit
Children with identified organic gastrointestinal disease or those without LTP or nickel sensitization are unlikely to directly benefit from findings in terms of symptom-directed treatment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational investigation enrolling children (age ≥4) who meet Rome IV criteria for functional dyspepsia or irritable bowel syndrome to explore links with allergen sensitization. Participants provide clinical history and undergo allergy testing for LTP-specific IgE and likely nickel sensitization, with results correlated to symptom patterns and severity. The study is performed at the Department of Translational Medical Science, University of Naples Federico II, and will consider regional prevalence patterns noted in Italy. No investigational treatments are given; the focus is on characterizing sensitization and its relationship to functional gastrointestinal presentations.
Why it matters
Potential benefit: If a clear link is found, identifying LTP or nickel sensitization could help guide targeted dietary advice or allergy-focused management for affected children.
How similar studies have gone: Previous research has established that nsLTPs are a common cause of food allergy in Mediterranean populations, but their specific role in functional gastrointestinal disorders is less well studied.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age at least of 4 years * both sexes * history of functional dyspepsia (according to the Rome IV criteria, at least one symptom among the following - duration of symptoms greater than 4 days per month and for more than 2 consecutive months, feeling of post-prandial fullness, early satiety, pain and/or epigastric burning not associated with defecation - in the absence of organic disease) and irritable bowel syndrome (according to the Rome IV criteria, including all of the following criteria for at least 2 months prior to diagnosis - abdominal pain for at least 4 days per month associated with one/more of the following: change in EF, change in stool shape/appearance, if constipation is noticed, pain does not resolve with resolution of constipation - in the absence of organic disease). * written informed consent from the parents of the participants and the participants if over 6 years of age. Exclusion Criteria: * Age \< 4 years * Evidence of gastrointestinal pathology of organic nature (GERD, Helicobacter Pylori infection, eosinophilic diseases, celiac disease, chronic inflammatory bowel disease, chronic pancreatitis, cholelithiasis, neoplasia); motility disorder on a post-infectious basis; food intolerances (e.g. lactose), carbohydrate malabsorption, use of ASAs, NSAIDs; chronic systemic diseases (diabetes, amyloidosis, neuropathy) and autoimmune diseases; neuropsychiatric disorders; pregnancy.
Where it's running
-
Department of Traslational Medical Science - University of Naples Federico II
Naples, Naples, Italy Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.