Effects of Ultramicronized Palmitoylethanolamide on Smell, Taste, and Sensory Sensitivity in Children With Autism Spectrum Disorder.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with autism
排除标准
- •No parental consensus to the study enrollment
研究者
Arianna Di Stadio
Associate Professor
University of Campania Luigi Vanvitelli