Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:02 AM
Study NCT ID:
NCT07419659
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-02-27
First Post:
2026-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Lactic Acid Bacteria in Patients With Attention-Deficit/Hyperactivity Disorder
Sponsor:
I-Ching Chou
Organization:
Study Overview
Official Title:
Effects of Lactic Acid Bacteria in Patients With Attention-Deficit/Hyperactivity Disorder
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: