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

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).

Study Overview

• Status: Recruiting
• Conditions: Attention Deficit and Hyperactivity Disorders
• Intervention / Treatment: Dietary supplement: multiple-strain probiotics

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: YU-SHIAN CHENG, MDPhD; Phone Number: 00886978173901; Email: n043283@gmail.com

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 831
    • Recruiting
    • Tsyr-HueyMentalHospital
    • Contact: YU-SHIAN CHENG, MDPhD; Phone Number: 00886987173901; Email: n043283@gmail.com
    • Principal Investigator: YU-SHIAN CHENG, MDPhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: multiple-strain probiotics	Dietary supplement: multiple-strain probiotics; Juice HA capsule which contains more than one strain of probiotics

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse events	any adverse events occurred during study	every one month for 3 months

Collaborators and Investigators

• Sponsor: Tsyr-Huey Mental Hospital
• Investigators: Principal Investigator: YU-SHIAN CHENG, MDPhD, Tsyr-Huey Mental Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2024
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: January 13, 2024
• First Submitted That Met QC Criteria: January 23, 2024
• First Posted (Actual): January 26, 2024

Study Record Updates

• Last Update Posted (Actual): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: ADHD; probiotics; quantitative electroencephalogram
• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: MultiProbioADHD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No