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Completed

NCT Number: NCT07631455

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

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.

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Key information

Conditions

Autism Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Nervous System Diseases Neurodevelopmental Disorders Neurologic Manifestations Olfaction Disorders Pathological Conditions, Signs and Symptoms Sensation Disorders Sensorial Disturbance Signs and Symptoms Smell Dysfunction Taste Alterations

Age range

Up to 10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CPR in Movimento

Latina, 04022, Italy

About this study

Eighty children will be sequentially enrolled and assigned using systematic alternating sequence (1:1 ratio) to the standard treatment (ST) group, treated with probiotics and omega-3 fatty acids, or the alternative treatment (AT) group, who received umPEA.

All children will be evaluated and classified for ASD severity using observation of free play and the Autism Diagnostic Observation Schedule II edition (ADOS-2) and Autism Diagnostic Interview-Revised (ADI-R) test; then participants will be classified according to DSM-5 as level 1, level 2 or level 3 based on their support needs.

The ST group used two oral supplements, one containing Lactobacillus and the other omega-3 fatty acids. The alternative treatment consisted of a 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).

The supplement had to be taken after meals.

A 6-month treatment duration will be applied.

The investigators will develop an ad-hoc designed multi-item questionnaire to investigate sensory disorders in particular smell and taste perceptions in children with ASD. This is a 11-item questionnaire by modifying some of the questions contained in the SSQ to analyze visual hypersensitivity auditory hypersensitivity auditory hyposensitivity , auditory regulation (hyper- or hypo- reactivity), taste and smell preference and perception.The questionnaire was named "Daily Sensory Observational Questionnaire" (D-SOQ) and consisted of closed-ended yes/no questions.

The questionnaire will be used to evaluate children at baseline (T0) and after 6 months of treatment (T1).

All children will perform Applied Behavior Analysis (ABA) treatment independently from the belonging group 8 hours per weeks divided into 4 sections of 2 hours each.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children with autism

Exclusion criteria

  • No parental consensus to the study enrollment

Treatment and study plan

supplement (Paidinil® HD, Epitech Group SpA, Saccolongo, Padova, Italy) containing 12% umPEA

Dietary Supplement

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

Dietary Supplement

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

Primary outcomes

  1. Changes of Smell perception in patients after treatment

    Time frame: 6 months

    Smell will be evaluated at the baseline and after 6 months of treatment using the ad-hoc designed questionnaire described in the material and method. The ad-hoc questionnaire -see material and method for details- is based on "yes" or "no" answers. There is no score limit, just presence or not (meaning improvement) of the concern

  2. Changes of taste in patients after treatment

    Time frame: 6 months

    Taste will be evaluated at the baseline and after treatment with umPEA using the ad-hoc designed questionnaire.The ad-hoc questionnaire -see material and method for details- is based on "yes" or "no" answers. There is no score limit, just presence or not (meaning improvement) of the concern

Secondary outcomes

  1. Changes of Auditory sensation after treatment

    Time frame: 6 months

    The auditory functions will be evaluated at the baseline and after treatment with umPEA using the ad-hoc designed questionnaire.The ad-hoc questionnaire -see material and method for details- is based on "yes" or "no" answers. There is no score limit, just presence or not (meaning improvement) of the concern

  2. Changes of visual sensations after treatment

    Time frame: 6 months

    Visual sensations will be evaluated at the baseline and after treatment with umPEA using the ad-hoc designed questionnaire.The ad-hoc questionnaire -see material and method for details- is based on "yes" or "no" answers. There is no score limit, just presence or not (meaning improvement) of the concern

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study title

Effects of Ultramicronized Palmitoylethanolamide on Smell, Taste, and Sensory Sensitivity in Children With Autism Spectrum Disorder.

Acronym: SmeTasAu

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jun 8, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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