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

Conditions: Autism, Smell Dysfunction, Taste Alterations, Sensorial Disturbance

Sex: All

Ages: N/A – 10 Years

Healthy volunteers: No

Phase: NA

Enrollment: 80

Sponsor: University of Campania Luigi Vanvitelli

Location: CPR in Movimento Latina

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.

Eligibility Criteria

Inclusion Criteria: * Children with autism Exclusion Criteria: * No parental consensus to the study enrollment

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07631455). StuddyBuddy aggregates publicly available trial information.