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Multi-strain Probiotics for ADHD

Therapeutic Effects of Multiple-strain Probiotics for Children With ADHD Based on Assessment of Standardized Attention Tests and Quantitative Electroencephalogram: a Single Arm Pilot Study

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06226584
Enrollment
30
Registered
2024-01-26
Start date
2024-01-03
Completion date
2024-11-30
Last updated
2024-01-26

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

Conditions

Attention Deficit and Hyperactivity Disorders

Keywords

ADHD, probiotics, quantitative electroencephalogram

Brief summary

Probiotics are widely used as supplement for various neurodevelopmental disorders. The mechanism of their therapeutic potential lies in the gut-brain axis, a two-way communication pathway through the neuroendocrine system. In the past, there have been many experiments to study the possible efficacy of probiotics in patients with ADHD. Although some studies have shown that probiotics can improve ADHD symptoms, most studies have used behavioral rating scales to evaluate. As a result, it is susceptible to informant bias. Standardized attentional tests and quantitative electroencephalogram (qEEG) can provide more objective data and detect possible changes in brain networks. Such changes may precede behavioral phenotypes. Therefore, the purpose of this study is mainly to detect the therapeutic effect of multiple strains of probiotics in patients with attention deficit hyperactivity disorder by using standardized attention tests and quantified brain waves (qEEG).

Interventions

DIETARY_SUPPLEMENTmultiple-strain probiotics

Juice HA capsule which contains more than one strain of probiotics

Sponsors

Tsyr-Huey Mental Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 11 Years
Healthy volunteers
No

Inclusion criteria

A patient is eligible for the study if all of the followings apply: 1. 8-11 children diagnosed with ADHD by board certified pediatric psychiatrist according to DSM-5 (assessment tool using SNAP criteria, at least 6/9 symptoms of inattention and/or hyperactivity/impulsivity (≧2/3 on each severity scale) on parents' and teachers' observation) 2. On stable psychotropic mediations (i.e. no change in dose of methylphenidate or antipsychotics) for past 8 weeks

Exclusion criteria

Any patient meeting any of the

Design outcomes

Primary

MeasureTime frameDescription
The Swanson, Nolan and Pelham Chinese (SNAP) rating scalesevery one month for 3 monthsfor behavioral symptoms of ADHD, the minimum and maximum values (0-78), higher scores mean a worse outcome
Conners' Continuous Performance Test 3rd Editionpre- and post-intervention (3 months)a task-oriented computerised assessment of attention-related problems in individuals aged 8 years and older
quantitative electroencephalogrampre- and post-intervention (3 months)measurement of brain wave patterns and coherence

Secondary

MeasureTime frameDescription
adverse eventsevery one month for 3 monthsany adverse events occurred during study

Countries

Taiwan

Contacts

Primary ContactYU-SHIAN CHENG, MDPhD
n043283@gmail.com00886978173901

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026