Effects of Lactic Acid Bacteria in Patients With Attention-Deficit/Hyperactivity Disorder

Condition(s) studied

Investigational drug(s) / intervention(s)

postbiotics: The participants will consume 2 capsules of postbiotics supplement per day for 8 weeks

Study 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.

Eligibility

Primary outcome measure(s)

• Total Scores of Clinical Symptoms-Swanson, Nolan, and Pelham Rating Scale-4th Edition(SNAP-IV) — 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 — 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 — 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.

Trial sites (1)

Other trials for the same condition