Nickel and LTP sensitization in children with functional gastrointestinal disorders
The Role of NIchel and LTPs Sensitization in Functional Gastrointestinal Disorders: the NILT Study
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 4 Years to 65 Years |
| Sex | All |
| Sponsor | Federico II University Academic / other |
| Locations | 1 site (Naples) |
| Trial ID | NCT07105865 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Naples
- Department of Traslational Medical Science - University of Naples Federico II — Naples, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.