Effects of Lactic Acid Bacteria in Patients With Attention-Deficit/Hyperactivity Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: postbiotics.
- Who it may be relevant to
- Registry conditions: ADHD - Attention Deficit Disorder With Hyperactivity, ADD/ADHD. Basic parameters: 6 years — 13 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Dietary supplement postbiotics
The participants will consume 2 capsules of postbiotics supplement per day for 8 weeks
Primary outcome measures
- Total Scores of Clinical Symptoms-Swanson, Nolan, and Pelham Rating Scale-4th Edition(SNAP-IV) [Time frame: Baseline, 8th week and 12th week]
- Total Scores of Child Behavior Checklist [Time frame: Baseline, 8th week and 12th week]
- Changes of Sleep and Appetite [Time frame: Baseline, 8th week and 12th week]
Secondary outcome measures (6)
- Parenting Stress Index, Fourth Edition Short Form , PSI-4-SF [Time frame: Baseline and 8th week]
- Visual Analogue Scale for Gastrointestinal Symptoms, VAS-GI [Time frame: Baseline and 8th week]
- Clinical Global Impressions-Severity, CGI-S and Clinical Global Impressions-Improvement, CGI-I [Time frame: Baseline, 8th week and 12th week]
- The Patient Global Impression of Change (PGI-C) [Time frame: 8th week and 12th week]
- Conners Continuous Performance Test 3rd Edition, Conners CPT 3 [Time frame: Baseline and 8th week]
- Oxidative stress [Time frame: Baseline and 8th week]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Taiwan · 1 center
- China Medical University Hospital — Taichung
Identifiers
NCT: NCT07419659 · CMUH114-REC3-212