Effects of Lactic Acid Bacteria in Patients With Attention-Deficit/Hyperactivity Disorder
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: postbiotics.
- Кому может быть актуально
- Состояния в реестре: ADHD - Attention Deficit Disorder With Hyperactivity, ADD/ADHD. Базовые параметры: 6 лет — 13 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Тайвань
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Обзор
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.
Подробное описание
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
Вмешательства
- Пищевая добавка postbiotics
The participants will consume 2 capsules of postbiotics supplement per day for 8 weeks
Первичные конечные точки
- Total Scores of Clinical Symptoms-Swanson, Nolan, and Pelham Rating Scale-4th Edition(SNAP-IV) [Срок оценки: Baseline, 8th week and 12th week]
- Total Scores of Child Behavior Checklist [Срок оценки: Baseline, 8th week and 12th week]
- Changes of Sleep and Appetite [Срок оценки: Baseline, 8th week and 12th week]
Вторичные конечные точки (6)
- Parenting Stress Index, Fourth Edition Short Form , PSI-4-SF [Срок оценки: Baseline and 8th week]
- Visual Analogue Scale for Gastrointestinal Symptoms, VAS-GI [Срок оценки: Baseline and 8th week]
- Clinical Global Impressions-Severity, CGI-S and Clinical Global Impressions-Improvement, CGI-I [Срок оценки: Baseline, 8th week and 12th week]
- The Patient Global Impression of Change (PGI-C) [Срок оценки: 8th week and 12th week]
- Conners Continuous Performance Test 3rd Edition, Conners CPT 3 [Срок оценки: Baseline and 8th week]
- Oxidative stress [Срок оценки: Baseline and 8th week]
Критерии участия
Критерии включения
- Age 6-13 years old
- Has been diagnosed with ADHD and is taking medication regularly or has not yet started medication.
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Другое
Центры проведения
Тайвань · 1 центр
- China Medical University Hospital — Taichung
Идентификаторы
NCT: NCT07419659 · CMUH114-REC3-212