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.
Visão geral do estudo
Status
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Latina, Itália, 04022
- CPR in Movimento
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Children with autism
Exclusion Criteria:
- No parental consensus to the study enrollment
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: Standard Treatment
Lactobacillus and omega-3 fatty acids combined
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Combination will be performed for 6 months using dose 1:1 of each element
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Experimental: Alternative Treatment
supplement (Paidinil® HD, Epitech Group SpA, Saccolongo, Padova, Italy) containing 12% umPEA
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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).
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Changes of Smell perception in patients after treatment
Prazo: 6 months
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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
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6 months
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Changes of taste in patients after treatment
Prazo: 6 months
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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
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6 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Changes of Auditory sensation after treatment
Prazo: 6 months
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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
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6 months
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Changes of visual sensations after treatment
Prazo: 6 months
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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
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6 months
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- 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.
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Conclusão do estudo (Real)
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Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
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Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
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Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Transtorno do Espectro Autista
- Manifestações Neurológicas
- Doenças do Sistema Nervoso
- Transtornos Mentais, Desordem Mental
- Distúrbios da Sensação
- Distúrbios do Neurodesenvolvimento
- Transtornos Invasivos do Desenvolvimento Infantil
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Transtorno Autista
- Distúrbios do olfato
- Lacteol
Outros números de identificação do estudo
- CPRXX1425
Plano para dados de participantes individuais (IPD)
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- PROTOCOLO DE ESTUDO
- SEIVA
- CSR
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