Clinical Trial

Ultramicronized Palmitoylethanolamide for Smell, Taste in Children With Autism Spectrum Disorder.

Study acronym: SmeTasAu
Completed
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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.
Trial Details
NCT Number NCT07631455
Lead Sponsor University of Campania Luigi Vanvitelli
Conditions Autism, Smell Dysfunction, Taste Alterations, Sensorial Disturbance
Enrollment 80 participants
Start Date 2024-04-01
Primary Completion 2024-10-30 (estimated)
Study Completion 2025-11-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-08