The Effectiveness of Probiotic Supplements in Attention Deficit-Hyperactivity Disorder

The Effectiveness of Treatment with Probiotic Supplements Added to the Usual Treatment (Medical Treatment for Children with Parenting Training Sessions for Parents) in Children Suffering from Attention Deficit-Hyperactivity Disorder Referred to Specialized Treatment Centers for Child and Adolescent Psychiatry

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20211004052670N6

Enrollment

Registered

2024-01-20

Start date

2023-12-22

Completion date

Unknown

Last updated

2024-01-22

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, combined type

Interventions

Intervention 1: Control groupThe control group was instructed to administer a capsule (contains placebo) once daily for a duration of 1.5 months concurrently with their routine medication. Drug utiliz

Eligibility

Sex/Gender

All

Age

6 Years to 12 Years

Inclusion criteria

Inclusion criteria: Children with Attention Deficit-Hyperactive Disorder with 6 to 12 years old. No change in treatment regimen during the last two months. Consent to participate in the study.

Exclusion criteria

Exclusion criteria: Taking anti-depressant drugs, anti-psychotic drugs and mood stabilizers. Children with anxiety (based on Hamilton Rating Scale for Depression) and with depression (based on Children Depression Inventory). Children with Inflammatory Bowel Disease, Celiac disease and Irritable bowel syndrome. Children with Diabetes.

Design outcomes

Primary

Measure	Time frame
Attention deficit-hyperactivity scale in attention deficit-hyperactivity rating scale. Timepoint: The questionnaire is filled in at the baseline visit and after 15 days of participating in parent training sessions (before the start of the intervention) and then 45 days later and after the end of taking the drug. Method of measurement: Attention deficit-hyperactivity rating scale.;Attention deficit-hyperactivity scale in Connors questionnaire. Timepoint: The questionnaire is filled in at the baseline visit and after 15 days of participating in parent training sessions (before the start of the intervention) and then 45 days later and after the end of taking the drug. Method of measurement: Connors questionnaire.;Quality of life score in Pediatric's Quality of Life Questionnaire. Timepoint: The questionnaire is filled in at the baseline visit and after 15 days of participating in parent training sessions (before the start of the intervention) and then 45 days later and after the end of taking the drug. Method of measurement: Pediatric's Quality of Life Questionnaire.	—

Measure

Time frame

Attention deficit-hyperactivity scale in attention deficit-hyperactivity rating scale. Timepoint: The questionnaire is filled in at the baseline visit and after 15 days of participating in parent training sessions (before the start of the intervention) and then 45 days later and after the end of taking the drug. Method of measurement: Attention deficit-hyperactivity rating scale.;Attention deficit-hyperactivity scale in Connors questionnaire. Timepoint: The questionnaire is filled in at the baseline visit and after 15 days of participating in parent training sessions (before the start of the intervention) and then 45 days later and after the end of taking the drug. Method of measurement: Connors questionnaire.;Quality of life score in Pediatric's Quality of Life Questionnaire. Timepoint: The questionnaire is filled in at the baseline visit and after 15 days of participating in parent training sessions (before the start of the intervention) and then 45 days later and after the end of taking the drug. Method of measurement: Pediatric's Quality of Life Questionnaire.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAfsaneh Karbasi Amel

Esfahan University of Medical Sciences

afsaneh_karbasi@med.mui.ac.ir+98 31 3641 1255

Outcome results

None listed

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