Some prebiotics and probiotics have been proposed to improve psychiatric symptoms in children with autism. However, few studies were placebo-controlled, and there is no study on persons with an attention deficit hyperactivity disorder (ADHD) diagnosis. Our aim was to study effects of Synbiotic 2000 on psychiatric symptoms and functioning in children and adults with ADHD without an autism diagnosis. Children and adults (n=182) with an ADHD diagnosis completed the nine weeks randomized double-blind parallel placebo-controlled trial examining effects of Synbiotic 2000 on the primary endpoints ADHD symptoms, autism symptoms and daily functioning, and the secondary endpoint emotion regulation, measured using the questionnaires SNAP-IV, ASRS, WFIRS, SCQ, AQ and DERS-16. Levels at baseline of plasma C-reactive protein and soluble vascular cell adhesion molecule-1 (sVCAM-1), central to leukocyte-endothelial cell adhesion facilitating inflammatory responses in tissues, were measured using Meso Scale Discovery. Synbiotic 2000 and placebo improved ADHD symptoms equally well, and neither active treatment nor placebo had any statistically significant effect on functioning or sub-diagnostic autism symptoms. However, Synbiotic 2000, specifically, reduced sub-diagnostic autism symptoms in the domain restricted, repetitive and stereotyped behaviors in children, and improved emotion regulation in the domain of goal-directed behavior in adults. In children with elevated sVCAM-1 levels at baseline as well as in children without ADHD medication, Synbiotic 2000 reduced both the total score of autism symptoms, and the restricted, repetitive and stereotyped behaviors. In adults with elevated sVCAM-1 at baseline, Synbiotic 2000 significantly improved emotion regulation, both the total score and four of the five subdomains. To conclude, while no definite Synbiotic 2000-specific effect was detected, the analysis of those with elevated plasma sVCAM-1 levels proposed a reduction of autism symptoms in children and an improvement of emotion regulation in adults with ADHD. Trial registration number: ISRCTN57795429.

中文翻译：

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合生元对注意力缺陷多动障碍症状和日常功能的影响——一项双盲随机对照试验

一些益生元和益生菌已被提议用于改善自闭症儿童的精神症状。然而，很少有研究是安慰剂对照的，也没有关于患有注意力缺陷多动障碍 (ADHD) 诊断的人的研究。我们的目的是研究 Synbiotic 2000 对未诊断为自闭症的多动症儿童和成人的精神症状和功能的影响。诊断为 ADHD 的儿童和成人（n=182）完成了为期 9 周的随机双盲平行安慰剂对照试验，检查了 Synbiotic 2000 对主要终点 ADHD 症状、自闭症症状和日常功能以及次要终点情绪调节的影响，使用问卷 SNAP-IV、ASRS、WFIRS、SCQ、AQ 和 DERS-16 进行测量。血浆 C 反应蛋白和可溶性血管细胞粘附分子 1 (sVCAM-1) 的基线水平是白细胞 - 内皮细胞粘附促进组织炎症反应的核心，使用 Meso Scale Discovery 进行测量。Synbiotic 2000 和安慰剂同样能很好地改善 ADHD 症状，并且无论是积极治疗还是安慰剂对功能性或亚诊断性自闭症症状都没有任何统计学上的显着影响。然而，Synbiotic 2000，特别是减少了儿童受限、重复和刻板行为领域的亚诊断自闭症症状，并改善了成人目标导向行为领域的情绪调节。在基线时 sVCAM-1 水平升高的儿童以及未服用 ADHD 药物的儿童中，Synbiotic 2000 降低了自闭症症状的总分，并降低了受限制的、重复和刻板的行为。在基线时 sVCAM-1 升高的成年人中，Synbiotic 2000 显着改善了情绪调节，包括总分和五个子域中的四个。总而言之，虽然没有检测到明确的 Synbiotic 2000 特异性作用，但对血浆 sVCAM-1 水平升高的人的分析表明，儿童的自闭症症状减少，成人多动症的情绪调节得到改善。试用注册号：ISRCTN57795429。对血浆 sVCAM-1 水平升高的人的分析表明，儿童的自闭症症状减少，成人多动症的情绪调节得到改善。试用注册号：ISRCTN57795429。对血浆 sVCAM-1 水平升高的人的分析表明，儿童的自闭症症状减少，成人多动症的情绪调节得到改善。试用注册号：ISRCTN57795429。