Background Studies suggest that the bidirectional relationship existent between the gut microbiome (GM) and the central nervous system (CNS), or so-called the microbiome–gut–brain axis (MGBA), is involved in diverse neuropsychiatric diseases in children and adults. Aim and objectives The aim of the study was to assess the effect of probiotics supplementation as an adjunctive therapy in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) cases. Subjects and methods This was a randomized controlled study included 80 patients with ADHD diagnosed according to DSM-5 diagnostic criteria for ADHD with age ranging from 6 to 16 years old who are following up at the Child Psychiatry Clinics of both Children`s Hospital and Psychiatry Institute Faculty of medicine, Ain-Shams University, All patients randomly distributed into two equal groups, Group1:ADHD cases received probotic in addtion to atomoxetine and Group2: ADHD cases received atomoxetine without probiotic, all cases subjected to Conner’s Parent Rating Scales-Revised (CRS-R) and The Continuous Performance Test (CPT) before and after intervention. Results In group 1, there was significant decrease in mean differences between before and after intervention as regards Oppositional, inattentive, Hyperactive/impulsive and total scores after intervention in comparison with before intervention (p < 0.001). In group 2, the mean differences between before and after showed non-significant differences regarding Oppositional, inattentive and Hyperactive/impulsive scores (p > 0.05). There was statistically significant elevation (improvement) in the mean Correct trials, Correct targets, Correct foils, Target Accuracy Rate and foil Accuracy Rate scores of CPT among the group 1 compared with the group 2 (p < 0.05). On the other hand, group 1 had significant lower (improvement) scores of Commission errors, Omission errors, Correct Real Time Standard Deviation, Error real time mean Score and Error Real Time SD compared to group 2 (p < 0.05). In group 2, the mean differences between before and after showed non-significant differences regarding all sub items of CPT (p > 0.05). Conclusion Results of This study suggests that Probiotic supplementation could be beneficial as an adjunctive therapy in the treatment of ADHD cases.. This is a relatively new area of research and the number of included studies is limited.
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