the effect of probiotics on symptom control in children with attention deficit hyperactivity disorder

Investigating the effect of probiotics on symptom control in children with attention deficit hyperactivity disorder in neurology clinics in the city of Hamadan during the years 2024-2025

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250902067104N1

Enrollment

Registered

2025-09-25

Start date

2025-06-02

Completion date

Unknown

Last updated

2025-10-13

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

Conditions

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

Interventions

Intervention 1: Intervention group: Children will consume probiotic sachet (Lactobacillus and Bifidobacterium) daily for 12 weeks. Intervention 2: Control group: Children will consume Atomoxetine caps

Eligibility

Sex/Gender

All

Age

3 Years to 15 Years

Inclusion criteria

Inclusion criteria: children who are diagnosed with ADHD according to DSM V criteria meet the conditions for receiving hyperactivity medication family consent to participate in the program.

Exclusion criteria

Exclusion criteria: Lack of parental cooperation during the project. Changing the diagnosis during the plan Failure to take medication at the prescribed time. Discontinuing medication without consulting a doctor

Design outcomes

Primary

Measure	Time frame
Variable name: Conners Parents Rating Scale (CPRS) score Variable role: Dependent variable (primary outcome) Measurement method: 26-item Conners Parent Questionnaire Operational definition: The questionnaire is completed by parents and measures the severity of ADHD symptoms (inattention, hyperactivity/impulsivity) with a score range of 26 to 104. A higher score indicates greater symptom severity. Assessment time: Before the start of the intervention and one month after the start of the intervention Scoring method: A mean score of 1.5 or higher indicates the presence of the disorder; a score above 34 indicates the presence of Attention Deficit Disorder. Timepoint: At the beginning of the study (before the start of treatment) One month after the start of treatment. Method of measurement: The Conners Parents Rating Scale (CPRS) with 26 questions, completed by the child’s parents based on behaviors observed over the past month.	—

Measure

Time frame

Variable name: Conners Parents Rating Scale (CPRS) score Variable role: Dependent variable (primary outcome) Measurement method: 26-item Conners Parent Questionnaire Operational definition: The questionnaire is completed by parents and measures the severity of ADHD symptoms (inattention, hyperactivity/impulsivity) with a score range of 26 to 104. A higher score indicates greater symptom severity. Assessment time: Before the start of the intervention and one month after the start of the intervention Scoring method: A mean score of 1.5 or higher indicates the presence of the disorder; a score above 34 indicates the presence of Attention Deficit Disorder. Timepoint: At the beginning of the study (before the start of treatment) One month after the start of treatment. Method of measurement: The Conners Parents Rating Scale (CPRS) with 26 questions, completed by the child’s parents based on behaviors observed over the past month.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammedBaqer Ghareeb

Hamedan University of Medical Sciences

Md.gharib97@gmail.com+98 933 115 9861

Outcome results

None listed

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