This human study aims to evaluate the efficacy and safety of Lactococcus lactis KD10 powder for improving autism spectrum disorder symptoms in patients with autism spectrum disorder.
The purpose of this human study is to confirm the change rate (%) in the main symptoms of autism spectrum disorder after 12 weeks of taking Lactococcus lactis KD10 powder in subjects with autism spectrum disorder. In addition, we will conduct tests using various evaluation scales at the 12-week point to evaluate the degree of autism spectrum disorder symptoms and coexisting disease symptoms, and to evaluate the overall safety during the human study period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
* Food Name: Placebo of Lactococcus lactis KD10 * Ingredients: Natural pigment enteric-coated granules preparation * Appearance and Formulation: Granules/Powder * Dosage/Amount: 1 pack once a day * Dosage period and route: Oral intake of 1 pack once a day for 12 weeks 30 minutes after meals
* Food Name: Lactococcus lactis KD10 (health food) * Ingredients: Freeze-dried Lactococcus lactis enteric-coated granules preparation * Appearance and Formulation: Granules/Powder * Dosage/Amount: 1 pack once a day * Administration Period and Route: Oral intake of 1 pack once a day for 12 weeks 30 minutes after meals
Seoul national University buseoul national University bundang hospitalndang hospital
Seongnam-si, Gyeonggi-do, South Korea
Kyung Hee University Medical Center
Seoul, Kyungheedae-ro, Dongdaemun-gu, South Korea
Change rate of major symptoms of autism spectrum disorder (%)_Korean version of Vineland Adaptive Behavior Scale-II(K-VABS-II)
To determine the change rate (%) in major symptoms of autism spectrum disorder
Time frame: Baseline(0 weeks), 12 weeks
Social Skills Change Rate (%)_Korean version of Autism Diagnostic Observation Schedule version 2(K-ADOS-2)
To observe and diagnose patients with autism spectrum disorder.
Time frame: Baseline(0 weeks), 12 weeks
Social Skills Change Rate (%)_Korean version of Childhood Autism Rating Scale-2(K-CARS-2)
Developmental screening for children and adolescents suspected of having autism spectrum disorder
Time frame: Baseline(0 weeks), 12 weeks
Social Skills Change Rate (%)_Social Responsiveness Scale-2(SRS-2)
A questionnaire asking about the characteristics of children's social interactions.
Time frame: Baseline(0 weeks), 12 weeks
Social Skills Change Rate (%)_Korean version of Social Communication Questionnaire(K-SCQ)
Questions to screen for Autism Spectrum Disorder.
Time frame: Baseline(0 weeks), 12 weeks
Social Skills Change Rate (%)_Aberrant Behavior Checklist-II
Symptom checklist to assess problem behaviors in children with developmental disabilities.
Time frame: Baseline(0 weeks), 12 weeks
Level of functioning Change Rate (%)_Korean version of Wechsler Primary and Preschool Scale Intelligence-Ⅳ(K-WPPSI-Ⅳ)
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Assess cognitive abilities
Time frame: Baseline(0 weeks), 12 weeks
Level of functioning Change Rate (%)_CGI-S (Clinical Global Impression-Severity)
CGI-S is a scale that clinicians use to objectively measure the overall severity of a disease.
Time frame: Baseline(0 weeks), 12 weeks
Level of functioning Change Rate (%)_CGI-I (Clinical Global Impression-Improvement)
CGI-I is an assessment that evaluates whether the patient has improved or worsened after a therapeutic intervention compared to before the intervention.
Time frame: 12 weeks
Executive function Change Rate (%)_Children's Color Trail making Test 1&2(CCTT 1&2)
It is a neuropsychological test tool that evaluates cognitive function and can also evaluate attention and executive functions.
Time frame: Baseline(0 weeks), 12 weeks
Executive function Change Rate (%)_Stroop Test (Color & word)
Measures attention and response inhibition.
Time frame: Baseline(0 weeks), 12 weeks
Executive function Change Rate (%)_ Advanced Test of Attention(ATA)
A precise attention test program that measures sustained and selective attention and impulse control.
Time frame: Baseline(0 weeks), 12 weeks
Executive function Change Rate (%)_Korean version of ADHD Rating Scale-IV(K-ARS-4)
Assessing ADHD symptoms in school-aged children.
Time frame: Baseline(0 weeks), 12 weeks
Sleep disturbance Change Rate (%)_The Korean version of the Children's Sleep Habits Questionnaire
Assess overall sleep habits, including sleep behaviors, sleep problems, and sleep disorders in school-aged children.
Time frame: Baseline(0 weeks), 12 weeks
Anxiety Change Rate (%)_Korean version of Child Behavior Checklist (K-CBCL)
A scale for examining emotional and behavioral problems in children with autism spectrum disorder.
Time frame: Baseline(0 weeks), 12 weeks
Anxiety Change Rate (%)_Korean form of the State and Trait Anxiety Inventory for Children (K-STAIC)
Assessment tool to measure anxiety in children.
Time frame: Baseline(0 weeks), 12 weeks
GI trouble Change Rate (%)_Profile Of Toileting Issue (POTI)
A scale to check toilet use problems.
Time frame: Baseline(0 weeks), 12 weeks
Sensory Change Rate (%)_Short Sensory Profile-2 (SSP-2)
Measuring children's responses to sensory processing in everyday life.
Time frame: Baseline(0 weeks), 12 weeks
Parenting stress change rate (%)_Korean version of Parenting Stress Index Forth edition-Short Form (K-PSI-4-SF)
Parenting Stress Measurement Tool
Time frame: Baseline(0 weeks), 12 weeks