Effects of Lactic Acid Bacteria in Patients With Attention-Deficit/Hyperactivity Disorder:An Open Label Clinical Research
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- I-Ching Chou
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Total Scores of Clinical Symptoms-Swanson, Nolan, and Pelham Rating Scale-4th Edition(SNAP-IV)
Overview
Brief Summary
The study aims to evaluate whether postbiotics supplementation can improve ADHD symptoms, such as mood and sleep, in children. Furthermore, salivary biochemical profiles will be analyzed and dietary habits will be recorded to further explore the effects and mechanisms of action of postbiotics.
Research process: 80 subjects who meet the admission conditions will be recruited within three years after IRB approval. They will take the research capsules (postbiotics) in an open label design study and complete the 8-week intervention plus 4 weeks follow up trial period.
Detailed Description
In recent years, increasing attention has been directed toward the impact of lifestyle and dietary factors on cognitive function, mood, and sleep. Probiotics are defined as live microorganisms that, when administered in adequate amounts, confer health benefits to the host by modulating gut microbiota composition, intestinal barrier function, inflammatory responses, and antioxidant activity. Through these mechanisms, probiotics may contribute to host health by delaying disease progression, regulating pathological processes, and preventing disease-related complications. A growing body of basic and clinical evidence has further demonstrated associations between the gut microbiota, probiotic interventions, and a range of neuropsychiatric and neurodegenerative conditions, including stress-related disorders, autism spectrum disorder (ASD), anxiety, depression, and Parkinson's disease (PD).
In addition to live probiotics, increasing interest has been directed toward postbiotics, which are defined as preparations of inanimate microorganisms and/or their components that confer health benefits to the host. Postbiotics contain a variety of bioactive constituents, including cell wall components (such as peptidoglycans and lipoteichoic acids), intracellular contents, and microbial metabolites produced during fermentation. These components are known to interact with host immune and metabolic pathways, contributing to immunomodulatory, anti-inflammatory, antioxidant, and gut barrier-enhancing effects. Importantly, postbiotics may exert biological activities similar to those of live probiotics while avoiding several limitations associated with viable microorganisms.
The strain investigated in the present study is heat-treated Lactiplantibacillus plantarum. Although heat treatment abolishes its capacity for replication, the resulting postbiotic retains multiple bioactive components, including intact cell wall structures and postbiotic metabolites. Heat treatment also enhances product stability and shelf life, reduces sensitivity to environmental conditions, and ensures consistent dosing, thereby improving suitability for clinical application. From a safety perspective, postbiotics eliminate the risk of microbial translocation, infection, or horizontal gene transfer, which may be of particular concern in vulnerable populations such as children, the elderly, or individuals with compromised immune function. Consequently, postbiotics are increasingly regarded as a safe and reliable alternative to live probiotics in clinical research and practice.
Heat-treated Lactiplantibacillus plantarum has been investigated in several clinical contexts, including ASD, attention-deficit/hyperactivity disorder (ADHD), and Parkinson's disease, demonstrating potential benefits in modulating neurological and behavioral outcomes. Collectively, these findings support the rationale for further investigation of postbiotic interventions as a stable, safe, and biologically active strategy for targeting gut-brain axis-related conditions
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 13 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 6-13 years old
- •Has been diagnosed with ADHD and is taking medication regularly or has not yet started medication.
Exclusion Criteria
- •Have taken antibiotics within one month or are receiving antibiotic treatment
- •Have used probiotic products in powder, capsule or tablet form within one month (including yogurt, yogurt, Yakult and other related foods)
- •Those who are allergic to lactic acid bacteria products
- •Obtain a disability certificate
- •Participating in other human research
- •Determined unsuitable by the investigator
Arms & Interventions
Postbiotics
Dietary Supplement
Intervention: postbiotics (Dietary Supplement)
Outcomes
Primary Outcomes
Total Scores of Clinical Symptoms-Swanson, Nolan, and Pelham Rating Scale-4th Edition(SNAP-IV)
Time Frame: Baseline, 8th week and 12th week
The SNAP-IV is used assess symptoms of ADHD (Attention Deficit Hyperactivity Disorder) in children and adolescents. It consists of a series of questions that rate the severity of behaviors such as inattention, hyperactivity, and impulsivity, based on teacher and parent observations. The scale includes both parent and teacher versions, allowing for a comprehensive view of a child's behavior in different environments. The scoring system rates each behavior on a 4-point scale from 0 (never or rarely) to 3 (very often), and higher total scores indicate more significant ADHD symptoms. The results help clinicians in diagnosing ADHD and monitoring treatment progress.
Total Scores of Child Behavior Checklist
Time Frame: Baseline, 8th week and 12th week
This parent-reported questionnaire is a comprehensive assessment tool for identifying behavioral and emotional problems in children. It includes 100 items (scored 0-3) covering multiple domains such as anxiety, depression, social issues, and aggressive behavior, providing a detailed profile of the child's psychological functioning. The score ranges from 0-200, with a higher score representing higher concern of behavior problems.
Changes of Sleep and Appetite
Time Frame: Baseline, 8th week and 12th week
Use Fitbit and sleep diary to monitor the bedtime resistance, sleep resistance, sleep disordered breathing, night-waking, daytime sleepiness and sleep onset delay. Diet diary and InBody to monitor the change of appetite and body weight.
Secondary Outcomes
- Visual Analogue Scale for Gastrointestinal Symptoms, VAS-GI(Baseline and 8th week)
- Parenting Stress Index, Fourth Edition Short Form , PSI-4-SF(Baseline and 8th week)
- Clinical Global Impressions-Severity, CGI-S and Clinical Global Impressions-Improvement, CGI-I(Baseline, 8th week and 12th week)
- The Patient Global Impression of Change (PGI-C)(8th week and 12th week)
- Conners Continuous Performance Test 3rd Edition, Conners CPT 3(Baseline and 8th week)
- Oxidative stress(Baseline and 8th week)
Investigators
I-Ching Chou
MD
China Medical University Hospital