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Abstract
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.
Highlights
Attention deficit hyperactivity disorder (ADHD) is characterized by persistent features of inattention and/or hyperactivity-impulsivity leading to functioning impairments in areas such as work/school, social relations and family settings (Austerman, 2015), and is often associated with emotion dysregulation
Differences between treatment types (Synbiotic 2000 compared to placebo) in scale score changes over time were tested using analysis of covariance (ANCOVA) with outcome variable being the respective follow-up score adjusting for the corresponding baseline score, age and sex
Sensitivity analyses of treatment type effects on psychiatric symptoms were performed in subgroups: (i) plasma soluble vascular cell adhesion molecule-1 (sVCAM-1) level > 519519.7 mg/L versus sVCAM-1 level ≤ 519519.7 mg/L, and (ii) ADHD medication [yes/no]
Summary
Attention deficit hyperactivity disorder (ADHD) is characterized by persistent features of inattention and/or hyperactivity-impulsivity leading to functioning impairments in areas such as work/school, social relations and family settings (Austerman, 2015), and is often associated with emotion dysregulation. Most patients with ADHD are treated with pharmacological agents for long periods, a treatment directed only against symptoms and frequently associated with negative side effects (Storebø, 2015; Castells et al, 2018). Nutritional deficiencies of fatty acids, zinc and iron have been observed in children with ADHD, and correlations with ADHD symptom severity were reported (Curtis and Patel, 2008). Dietary supplementation has been proposed as a possible option to ameliorate some ADHD symptoms (Heilskov Rytter, 2015). Omega-3 fatty acids had a stable, but small, positive effect on ADHD symptoms (Chang, 2018)
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