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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210531051454N2
Enrollment
88
Registered
2022-07-02
Start date
2022-07-16
Completion date
Unknown
Last updated
2022-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

attention deficit hyperactivity disorder. Attention-deficit hyperactivity disorder, predominantly inattentive type

Interventions

Intervention 1: Intervention group: Bioflora capsules (Active substance: lactobacillus acidophilus, bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum and other ingredients: Magne
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 Z

Sponsors

Guilan University of Medical Sciences, Vice-Chancellor for Research & Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
7 Years to 12 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: Having Psychiatric and medical comorbid disorders simultaneous use of supplements or drugs that interfere with treatment

Design outcomes

Primary

MeasureTime frame
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).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Rabipour

Islamic Azad University

sadafrabipour62@gmail.com+98 13 3347 2099

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026