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

June 5, 2026 updated by: Arianna Di Stadio, University of Campania Luigi Vanvitelli

Effects of Ultramicronized Palmitoylethanolamide on Smell, Taste, and Sensory Sensitivity 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Latina, Italy, 04022
        • CPR in Movimento

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Children with autism

Exclusion Criteria:

  • No parental consensus to the study enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Treatment
Lactobacillus and omega-3 fatty acids combined
Dietary supplement: Lactobacillus and Omega Fatty acids
Combination will be performed for 6 months using dose 1:1 of each element
Experimental: Alternative Treatment
supplement (Paidinil® HD, Epitech Group SpA, Saccolongo, Padova, Italy) containing 12% umPEA
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campania Luigi Vanvitelli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Actual)

October 30, 2024

Study Completion (Actual)

November 1, 2025

Study Registration Dates

First Submitted

May 15, 2026

First Submitted That Met QC Criteria

June 5, 2026

First Posted (Actual)

June 8, 2026

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 5, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPRXX1425

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

General data anonymized about patients

IPD Sharing Time Frame

12 months

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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