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IRCT20210531051454N2 IRCT 2022-07-02 Guilan University of Medical Sciences, Vice-Chancellor for Research & Technology The role of probiotic supplements in the recovery of children with attention deficit hyperactivity disorder 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 2022-07-16 anticipated 88 Complete https://irct.ir/trial/63543 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 attention deficit hyperactivity disorder. Intervention 1: Intervention group: Bioflora capsules (Active substance: lactobacillus acidophilus, bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum and other ingredients: Magnesium stearate, Maltodextrin), produced by Tak Zhen Zist Pharmaceutical Company; for two months (one per day), 1.8 × 109 CFU/Capsule. Intervention 2: Control group: Placebo consumption is intended for two months (one per day) for each participant. 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 lactobacillus acidophilus, bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum strains in placebo. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to the decision to further research in this area
public Fatemeh Rabipour
Department of Psychology, Rasht Branch, Islamic Azad University, Darvazeh Lakan Street, Gas Square
Rasht Iran (Islamic Republic of) 4147654919 +98 13 3347 2099 sadafrabipour62@gmail.com Islamic Azad University scientific Dr. Saeid Doaei
Guilan University of Medical Sciences (Health and Environmental Research Center), behind the building of the Radio and Television Organization, Resalat Street
Rasht Iran (Islamic Republic of) 4185733411 +98 13 3384 9411 sdoaee@yahoo.com Guilan University of Medical Sciences Iran (Islamic Republic of) Diagnosis of attention deficit- hyperactivity disorder 7-12 years old having informed consent to participate in research having normal IQ rate (85 to 115) children under standard treatment with Ritalin Body mass less than +2 standard deviation 7 years 12 years Both Having Psychiatric and medical comorbid disorders simultaneous use of supplements or drugs that interfere with treatment F90.0 Attention-deficit hyperactivity disorder, predominantly inattentive type Treatment - Other Placebo Intervention group: Bioflora capsules (Active substance: lactobacillus acidophilus, bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum and other ingredients: Magnesium stearate, Maltodextrin), produced by Tak Zhen Zist Pharmaceutical Company; for two months (one per day), 1.8 × 109 CFU/Capsule Control group: Placebo consumption is intended for two months (one per day) for each participant. 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 lactobacillus acidophilus, bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum strains in placebo. Executive functions. Timepoint: Before intervention, after intervention, two months after intervention. Method of measurement: BRIEF' Executive Function Questionnaire (parent form). Attention deficit. Timepoint: Before intervention, after intervention, two months after intervention. Method of measurement: Swanson, Nolan and Pelham Rating Scale (SNAP-IV). Hyperactivity. Timepoint: Before intervention, after intervention, two months after intervention. Method of measurement: Swanson, Nolan and Pelham Rating Scale (SNAP-IV). Impulsivity. Timepoint: Before intervention, after intervention, two months after intervention. Method of measurement: Swanson, Nolan and Pelham Rating Scale (SNAP-IV). Guilan University of Medical Sciences, Vice-Chancellor for Research & Technology Approved 2022-02-23 Ethics Committee of Guilan University of Medical Sciences Ethics Committee of Guilan University of Medical Sciences,In front of Shahrivar 17 hospital, Shahid Siadati Street, Namjoo Street Rasht Guilan Iran (Islamic Republic of)