The effectiveness of probiotic supplement as an adjunctive therapy on executive functions and the severity of symptoms of inattention, hyperactivity and impulsivity in children with attention deficit hyperactivity disorder: A randomized, double-blind, placebo-controlled trial

To determine the effectiveness of probiotic supplement as adjunctive therapy on executive functions (behavior regulation skills and metacognition skills) and symptom severity (inattention, hyperactivity and impulsivity) in children with attention deficit hyperactivity disorder

randomized, double-blind, placebo-controlled trial. 44 patients in each group

The study will be performed in Shafa Hospital in Rasht. The experimental group (n = 44) received bioflora probiotic supplement for 2 months (n = 60), and the control group (n = 44) received placebo for 2 months (n = 60).The evaluation will be implemented again after the intervention is terminated and also two months later, to gather post-test and follow-up data.

Inclusion criteria include having attention deficit hyperactivity disorder (ADHD), age group 7 to 12 years and being treated with Ritalin. exclusion criteria include Camorbid with other severe psychiatric and medical disorders, drug interactions, and concomitant use of similar supplements.

Intervention group: Bioflora capsules, produced by Tak Zhen Zist Pharmaceutical Company; for two months (one per day), 1.8 × 109 CFU/Capsule, and Control group: Placebo consumption for two months (one per day), Placebo is produced by Tak Zhen Zist Pharmaceutical Company and is quite similar to a probiotic supplement in shape, color, size and packaging, even the available fillers or excipients (Magnesium stearate, Maltodextrin).The only difference is the absence of strains in placebo.

executive functions, inattention, hyperactivity and impulsivity

88 people will be selected based on the inclusion criteria and will be assigned by web-based randomization method (https://www.randomizer.org) as experimental and control groups (each group 44 people). Allocation concealment will be done using sequentially numbered, opaque sealed envelopes (SNOSE). Based on the research sample size, several aluminum envelopes will be prepared; each random sequence will be recorded on a card and the cards will be placed into the separate envelopes respectively. To maintain the random sequence, the envelopes will be numbered in the same way on their outer surface. In the end, the flaps of envelopes will be glued and orderly placed in a box. At the beginning of the intervention, the envelopes will be opened in order and the assigned group of the relevant participants will be revealed.

In this study, each step will be performed by one of the team researchers without informing the other members of the research team. In the first stage, participants will be interviewed by a psychiatrist and then the names of the participants (without further information) will be presented to the person responsible for randomization and assessment. Assessor will not know about the participants characteristics and how they are allocated. In addition, the participants will not know whether they are positioned as an experimental group or a control group; Because placebo is quite similar to a probiotic supplement in shape, color, size and packaging and participants will not be aware of the type of intervention received. Finally, the statistical analyst will be selected outside the research team and will not have any information about the details of the study.

Due to the decision to further research in this area

There is not a plan to make this available

There is not a plan to make this available

There is not a plan to make this available

There is not a plan to make this available

There is not a plan to make this available

There is not a plan to make this available