Multi-strain Probiotics for ADHD

Not Applicable

Recruiting

• Conditions: Attention Deficit and Hyperactivity Disorders
• Interventions: Dietary Supplement: multiple-strain probiotics

• Registration Number: NCT06226584
• Lead Sponsor: Tsyr-Huey Mental Hospital

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study Start: 2024-01-03
• Study First Submitted: 2024-01-13
• Study First Submitted QC: 2024-01-23
• Last Update Submitted: 2024-01-23
• Study First Posted: 2024-01-26
• Last Update Posted: 2024-01-26
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 exclusion criteria will be excluded from study participation:

1. Patients with major mental or neurological diseases such as intellectual disability, autism group disorders, schizophrenia, severe depression, bipolar disorder, epilepsy, brain injury, etc.
2. Those who have serious gastrointestinal diseases, physiological diseases or genetic diseases.
3. Have used antibiotics or edible probiotic-related products (including drops, tablets, capsules, bacterial powder) in the past month.
4. Participated in other clinical research in the past month.
5. Vegetarians or those currently undergoing special diet therapy.
6. Evaluation by the pediatric psychiatrist not suitable for entering the test

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
multiple-strain probiotics	multiple-strain probiotics	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
adverse events	every one month for 3 months	any adverse events occurred during study

Trial Locations

Locations (1)

Tsyr-HueyMentalHospital; 🇨🇳 Kaohsiung, Taiwan