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

NCT07631455 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-06-08

No results posted yet for this study

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.

Conditions

  • Autism
  • Smell Dysfunction
  • Taste Alterations
  • Sensorial Disturbance

Interventions

DIETARY_SUPPLEMENT

Lactobacillus and Omega Fatty acids

Combination will be performed for 6 months using dose 1:1 of each element

DIETARY_SUPPLEMENT

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).

Sponsors & Collaborators

  • University of Campania Luigi Vanvitelli

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2024-10-30
Completion
2025-11-01

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07631455 on ClinicalTrials.gov