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

NCT07631455 | Completed

• 1 other identifier: CPRXX1425
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Changes of Smell perception in patients after treatment

  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

  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 Outcomes (2)

• Changes of Auditory sensation after treatment

  6 months

• Changes of visual sensations after treatment

  6 months

Study Arms (2)

Standard Treatment

ACTIVE COMPARATOR

Lactobacillus and omega-3 fatty acids combined

Dietary Supplement: Lactobacillus and Omega Fatty acids

Alternative Treatment

EXPERIMENTAL

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

Interventions

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).

Alternative Treatment

Lactobacillus and Omega Fatty acids DIETARY_SUPPLEMENT

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

Standard Treatment

Eligibility Criteria

• Age: Up to 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children with autism

You may not qualify if:

• No parental consensus to the study enrollment

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

CPR in Movimento

Latina, 04022, Italy

Location

Related Publications (6)

• Di Stadio A, Gallina S, Cocuzza S, De Luca P, Ingrassia A, Oliva S, Sireci F, Camaioni A, Ferreli F, Mercante G, Gaino F, Pace GM, La Mantia I, Brenner MJ. Treatment of COVID-19 olfactory dysfunction with olfactory training, palmitoylethanolamide with luteolin, or combined therapy: a blinded controlled multicenter randomized trial. Eur Arch Otorhinolaryngol. 2023 Nov;280(11):4949-4961. doi: 10.1007/s00405-023-08085-8. Epub 2023 Jun 28.

  PMID: 37380908 BACKGROUND

• D'Aloia A, Molteni L, Gullo F, Bresciani E, Artusa V, Rizzi L, Ceriani M, Meanti R, Lecchi M, Coco S, Costa B, Torsello A. Palmitoylethanolamide Modulation of Microglia Activation: Characterization of Mechanisms of Action and Implication for Its Neuroprotective Effects. Int J Mol Sci. 2021 Mar 17;22(6):3054. doi: 10.3390/ijms22063054.

  PMID: 33802689 BACKGROUND

• Famitafreshi H, Karimian M. Overview of the Recent Advances in Pathophysiology and Treatment for Autism. CNS Neurol Disord Drug Targets. 2018;17(8):590-594. doi: 10.2174/1871527317666180706141654.

  PMID: 29984672 BACKGROUND

• Nimbley E, Golds L, Sharpe H, Gillespie-Smith K, Duffy F. Sensory processing and eating behaviours in autism: A systematic review. Eur Eat Disord Rev. 2022 Sep;30(5):538-559. doi: 10.1002/erv.2920. Epub 2022 Jun 23.

  PMID: 35737818 BACKGROUND

• Danesh AA, Howery S, Aazh H, Kaf W, Eshraghi AA. Hyperacusis in Autism Spectrum Disorders. Audiol Res. 2021 Oct 14;11(4):547-556. doi: 10.3390/audiolres11040049.

  PMID: 34698068 BACKGROUND

• Hughes HK, Moreno RJ, Ashwood P. Innate Immune Dysfunction and Neuroinflammation in Autism Spectrum Disorder (ASD). Focus (Am Psychiatr Publ). 2024 Apr;22(2):229-241. doi: 10.1176/appi.focus.24022004. Epub 2024 Apr 10.

  PMID: 38680981 BACKGROUND

Related Links

• Sensory Responses in Autistic Individuals-A Narrative Review. Sensory Neuroscience 2025

MeSH Terms

Conditions

Autistic Disorder; Olfaction Disorders

Interventions

Lacteol

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Comparison between oral supplement

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: June 8, 2026
• Study Start: April 1, 2024
• Primary Completion: October 30, 2024
• Study Completion: November 1, 2025
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 12 months

Locations

IT (1)