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Ultramicronized Palmitoylethanolamide for Smell, Taste in Children With Autism Spectrum Disorder.
Sponsor: University of Campania Luigi Vanvitelli
Summary
Autism Spectrum Disorder (ASD) is frequently associated with atypical sensory processing across visual, auditory, olfactory, and gustatory domains, variably affecting quality of life and requiring personalized treatment. Palmitoylethanolamide (PEA), an endogenous fatty acid amide with anti-inflammatory properties, may alleviate these symptoms. This study wants to evaluate whether ultramicronized PEA (umPEA) improves sensory function in children with ASD compared to probiotics plus omega-3 fatty acids. Eighty children with ASD will be consecutively enrolled and assigned 1:1 to standard treatment (probiotics plus omega-3) or umPEA for six months. Sensory symptoms will be assessed at baseline (T0) and post-treatment (T1) using the 11-item Daily Sensory Observational Questionnaire (D-SOQ). Within- and between-group differences will be analyzed using chi-square tests.
Official title: Effects of Ultramicronized Palmitoylethanolamide on Smell, Taste, and Sensory Sensitivity in Children With Autism Spectrum Disorder.
Key Details
Gender
All
Age Range
Any - 10 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2024-04-01
Completion Date
2025-11-01
Last Updated
2026-06-08
Healthy Volunteers
No
Interventions
supplement (Paidinil® HD, Epitech Group SpA, Saccolongo, Padova, Italy) containing 12% umPEA
The treatment started with 5ml (600mg umPEA) for the first 15 days, then 10 ml (5ml twice a day) for a total of 180 days (six months of treatment).
Lactobacillus and Omega Fatty acids
Combination will be performed for 6 months using dose 1:1 of each element
Locations (1)
CPR in Movimento
Latina, Italy