AutismSmeTasAuNCT07631455
Ultramicronized Palmitoylethanolamide for Smell, Taste in Children With Autism Spectrum Disorder.
A study testing supplement (Paidinil® HD, Epitech Group SpA, Saccolongo, Padova, Italy) containing 12% umPEA and Lactobacillus and Omega Fatty acids in people with Autism and Smell Dysfunction, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 10 years
- Conditions the study is for
- Autism, Smell Dysfunction, Taste Alterations
- What is being tested?
- supplement (Paidinil® HD, Epitech Group SpA, Saccolongo, Padova, Italy) containing 12% umPEA and Lactobacillus and Omega Fatty acids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2024to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with autism
Who cannot join
- No parental consensus to the study enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Autism, Smell Dysfunction, Taste Alterations, Sensorial Disturbance
- Being tested
- supplement (Paidinil® HD, Epitech Group SpA, Saccolongo, Padova, Italy) containing 12% umPEA, Lactobacillus and Omega Fatty acids
- Medical subject headings
- Autistic Disorder, Olfaction Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supplement (Paidinil® HD, Epitech Group SpA, Saccolongo, Padova, Italy) containing 12% umPEADietary 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 acidsDietary supplement
Combination will be performed for 6 months using dose 1:1 of each element
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment | Active comparator | Lactobacillus and omega-3 fatty acids combined Receives: Dietary Supplement: Lactobacillus and Omega Fatty acids |
| Alternative Treatment | Experimental | supplement (Paidinil® HD, Epitech Group SpA, Saccolongo, Padova, Italy) containing 12% umPEA Receives: Dietary Supplement: supplement (Paidinil® HD, Epitech Group SpA, Saccolongo, Padova, Italy) containing 12% umPEA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 6 months
Secondary outcomes (2)
Changes of Auditory sensation after treatment
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
Measured: 6 months
Changes of visual sensations after treatment
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start1 Apr 2024
- Primary completion30 Oct 2024
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison between oral supplement
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arianna Di Stadio, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07631455
- Sponsor's protocol ID
- CPRXX1425
- Acronym
- SmeTasAu
- Status last verified
- Jun 2026
- First submitted
- 15 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: General data anonymized about patients
Publications
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.
PubMed 37380908D'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.
PubMed 33802689Famitafreshi 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.
PubMed 29984672Nimbley 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.
PubMed 35737818Danesh 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.
PubMed 34698068Hughes 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.
PubMed 38680981
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ultramicronized Palmitoylethanolamide on Smell, Taste, and Sensory Sensitivity in Children With Autism Spectrum Disorder.
- ClinicalTrials.gov ID
- NCT07631455
- Acronym / sponsor ID
- SmeTasAu / CPRXX1425
- Conditions
- Autism, Smell Dysfunction, Taste Alterations, Sensorial Disturbance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparison between oral supplement
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment | Active comparator | Dietary Supplement: Lactobacillus and Omega Fatty acidsLactobacillus and omega-3 fatty acids combined |
| Alternative Treatment | Experimental | Dietary Supplement: supplement (Paidinil® HD, Epitech Group SpA, Saccolongo, Padova, Italy) containing 12% umPEAsupplement (Paidinil® HD, Epitech Group SpA, Saccolongo, Padova, Italy) containing 12% umPEA |
Who may qualify
- Ages
- Up to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children with autism
Key exclusion criteria (1 listed)
- No parental consensus to the study enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| supplement (Paidinil® HD, Epitech Group SpA, Saccolongo, Padova, Italy) containing 12% umPEAThe 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). | Dietary supplement | Alternative Treatment |
| Lactobacillus and Omega Fatty acidsCombination will be performed for 6 months using dose 1:1 of each element | Dietary supplement | Standard Treatment |
Primary outcome
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
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
2 secondary outcomes
Changes of Auditory sensation after treatment
Time frame: 6 months
Changes of visual sensations after treatment
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Background: PubMed 37380908Di 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.
- Background: PubMed 33802689D'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.
- Background: PubMed 29984672Famitafreshi 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.
- Background: PubMed 35737818Nimbley 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.
- Background: PubMed 34698068Danesh 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.
- Background: PubMed 38680981Hughes 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.
- Individual participant dataSharing planned: Yes. General data anonymized about patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing supplement (Paidinil® HD, Epitech Group SpA, Saccolongo, Padova, Italy) containing 12% umPEA and Lactobacillus and Omega Fatty acids in people with Autism and Smell Dysfunction, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Smell perception in patients after treatment (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07631455, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.