Ultramicronized Palmitoylethanolamide for Smell, Taste in Children With Autism Spectrum Disorder. (SmeTasAu)
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.
Studieoversikt
Status
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Latina, Italia, 04022
- CPR in Movimento
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Children with autism
Exclusion Criteria:
- No parental consensus to the study enrollment
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Standard Treatment
Lactobacillus and omega-3 fatty acids combined
|
Combination will be performed for 6 months using dose 1:1 of each element
|
|
Eksperimentell: Alternative Treatment
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).
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes of Smell perception in patients after treatment
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes of Auditory sensation after treatment
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CPRXX1425
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .