Authors: Liu L. Yang, Miranda Stiernborg, Elin Skott, Jingjing Xu, Yujiao Wu, Rikard Landberg, Samsul Arefin, Karolina Kublickiene ,Vincent Millischer , Ida A. K. Nilsson, Martin Schalling, MaiBritt Giacobini , and Catharina Lavebratt.
Published: Nutrients (2023)
The study was conducted in vivo, in human participants (s.1)
Design: The study employed a randomized controlled design. All participants in this study, including ADHD patients and healthy controls, were recruited through a double-blind randomized controlled trial. Participants were randomly assigned to intervention or placebo groups. A placebo group was included for comparison as a control group. All participants were blind to the allocation.
Treatment: 9-week intervention with Synbiotic 2000 or placebo. Patients were randomly allocated to one of the two treatments: Synbiotic 2000 or placebo.
Where and when: Between January 2016 and June 2018 at psychiatric clinics in Stockholm, Sweden.
Sample size: The study included 248 patients with ADHD diagnosis,182 completed the intervention and 156 provided blood samples. (s.3)
Sample criteria: Children and adults with ADHD, 5–55 years old, on a stable pharmacological treatment (the last four weeks before recruitment), were not on antibiotic treatment (the last six weeks) and did not have a gastrointestinal (GI)-diagnosis (except irritable bowel syndrome), diabetes or celiac disease. In parallel, adult healthy individuals without an ADHD diagnosis fulfilling the same criteria were recruited along with the patients at the same period. The healthy controls included were from two categories, healthy family members from the patient’s households and unrelated individuals.
Analysed material: Blood samples, interview and questionnaires.
Results
The study revealed that persons with ADHD, especially children on ADHD medication, have higher-than-normal pro-inflammatory sICAM-1 and sVCAM-1 and lower SCFA levels in plasma and that children with ADHD also have higher levels of additional pro-inflammatory markers.
Treatment with Synbiotic 2000, compared to placebo, reduced IL-12/IL-23p40 levels and suggestively
reduced sICAM-1 and IL-2Rα levels in children.
Synbiotic 2000 also suggestively increased propionic acid levels, which, together with highly associated formic and acetic acid levels, in turn, correlated negatively with sICAM-1 and sVCAM-1 in the children and protected against IL-1β-induced sICAM-1 expression in vitro.
At baseline, adults with ADHD had higher pro-inflammatory sICAM-1 and sVCAM-1 and lower SCFA levels than controls. Children with ADHD had higher baseline sICAM-1, sVCAM-1, IL-12/IL-23p40, IL-2Rα, and lower formic, acetic, and propionic acid levels than adults with ADHD. sICAM-1, sVCAM-1, and propionic acid levels were more abnormal in children on medication.
Synbiotic 2000, compared to placebo, reduced IL-12/IL-23p40 and sICAM-1 and increased propionic acid levels in children on medication. (s.1)
The trial showed positive effects on autistic symptoms and emotion regulation in ADHD patients who, at baseline, had higher plasma levels of vascular inflammation markers. (s.2)
Children treated with Synbiotic 2000 showed a significant reduction of levels of IL12/IL23p40, sICAM-1, and TGF-β3 while children treated with placebo did not show any level change of any immune activity marker. (s.9).
Among children with ADHD, pro-inflammatory cytokine IL-12/IL-23p40 was reduced by Synbiotic 2000 compared to by placebo. (s.10).
For children who were currently on ADHD medication, Synbiotic 2000 manifested a significant reduction of IL-12/IL-23p40 and a suggestive reduction in sICAM-1 levels compared to placebo. For children not currently on ADHD medication, sIL-2Rα was suggestively reduced (s.10).
In children, the Synbiotic 2000 intervention, compared to the placebo, suggestively reduced pro-inflammatory IL-12/IL-23p40 levels.
In children on ADHD medication, Synbiotic 2000, compared to placebo, reduced IL-12/IL-23p40 levels significantly and reduced sICAM-1 levels suggestively. (s.14).
Indicative results
These findings suggest that treatment with Synbiotic 2000 reduces IL12/IL-23p40 and sICAM-1 and increases propionic acid levels in children with ADHD. Propionic acid, together with formic and acetic acid, may contribute to the lowering of the higher-than-normal sICAM-1 levels. (s.1).
The study reveals that persons with ADHD, especially children on ADHD medication, have higher-than-normal pro-inflammatory sICAM-1 and sVCAM-1 and lower SCFA levels in plasma and that children with ADHD also have higher levels of additional pro-inflammatory markers.
Treatment with Synbiotic 2000, compared to placebo, reduced IL-12/IL-23p40 levels and suggestively reduced sICAM-1 and IL-2Rα levels in children. Synbiotic 2000 also suggestively increased propionic acid levels, which, together with highly associated formic and acetic acid levels, in turn, correlated negatively with sICAM-1 and sVCAM-1 in the children and protected against IL-1β-induced sICAM-1 expression in vitro.
This suggests that Synbiotic 2000, in children with ADHD, reduces markers of intestinal and vascular inflammation, the latter in part through increasing SCFA levels. (s.17).
Previous studies have shown that ADHD medication in children is associated with elevated levels of the vascular inflammatory markers sICAM-1 and sVCAM-1 (s.10).
The findings warrant further studies to determine if persons with ADHD would benefit inflammation-wise from dietary intake of Synbiotic 2000 or a similar synbiotic (s.17).
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