An interventional study of supplement (Paidinil® HD, Epitech Group SpA, Saccolongo, Padova, Italy) containing 12% umPEA and Lactobacillus and Omega Fatty acids in Autism, Smell Dysfunction and Taste Alterations, sponsored by University of Campania Luigi Vanvitelli. Completed at 1 site in Italy. Open to participants aged Up to 10 Years. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by University of Campania Luigi Vanvitelli · Not applicable, Interventional, and Treatment
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.
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.
1,030 studies on the registry are indexed under Autistic Disorder; 266 are open to participants now.
This study's enrollment of 80 is above the median of 49 across 811 interventional studies indexed under Autistic Disorder.
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Exclusion Criteria:
Lactobacillus and omega-3 fatty acids combined
Dietary Supplement: Lactobacillus and Omega Fatty acids
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).
Combination will be performed for 6 months using dose 1:1 of each element
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
Time frame: 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
Time frame: 6 months
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
Time frame: 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
Time frame: 6 months
Plan to share: Yes — General data anonymized about patients
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: 12 months
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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