Clinical trial NCT06650644: A Study to Evaluate the Efficacy and Safety of Lactococcus Lactis KD10 Powder for Improving Autism Spectrum Symptoms in Children With Autism Spectrum Symptoms.
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Investigator-initiated Human Study to Evaluate the Efficacy and Safety of Lactococcus Lactis KD10 Powder in Improving Autism Spectrum Symptoms in Pediatric Patients With Autism Spectrum Disorder.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism spectrum disorder
Lactococcus lactis
Human Study
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
Collaborators: name: KoBioLabs
name: Korea University
First posted: 2024-10-21
Enrollment: 48
Sex: ALL
Minimum age (years): 36
Maximum age (years): 91
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Children aged 3 years or older and 7 years and 7 months or younger
2. Those diagnosed with autism spectrum disorder through a standardized diagnostic tool according to the diagnostic criteria for autism spectrum disorder in the DSM-5 (Diagnostic and Statistical Manual of Mental disorder-5) at the time of screening \[Diagnostic tool: Korean version of Autism Diagnostic Observation Schedule version 2 (K-ADOS-2), Korean version of Autism Diagnostic Interview-Revised (K-ADI-R)\] (However, if diagnosed with autism spectrum disorder through a diagnostic evaluation within 6 months of screening, only the K-ADOS-2 test will be re-evaluated.)
3. Those judged by the investigator on the day of screening to be able to consume the food for this human test (control food) without chewing it, with water or the provided puree
4. Those subjects or/and their legal representatives who voluntarily agreed to participate in this human test and signed a written consent form and a consent form for research on human-derived materials
5. A person who can provide reliable information on the condition of the test subject during the human test period, attend all planned visits to the institution, supervise the intake of food for human test, and have the participation of a parent or the same legal representative who can fully understand and speak Korean, and conduct a questionnaire evaluation of the subject.

Exclusion Criteria:

\[Screening Visit (Visit 1)\]

1. Those with the following medical history, concomitant diseases, or surgical history at the time of screening ① Severe psychosis that may affect this test other than autism spectrum disorder

   ② History of organic brain disease, neurological disorder, uncontrolled epilepsy, or seizures. However, simple febrile seizures can be included at the investigator's discretion

   ③ Genetic diseases (Rett syndrome, Down syndrome, Fragile X syndrome, etc.) However, participation is allowed at the investigator's discretion only if it is confirmed to be a genetic disease that does not affect the results of this test

   ④ Gastrointestinal diseases and surgical history that may affect the intestinal absorption of food for human testing (simple appendectomy, hernia surgery are allowed)

   ⑤ Those with sensory abnormalities such as congenital hearing loss
2. Those with uncontrolled medical conditions (including arrhythmia, cancer, severe heart/kidney disease) during the screening period
3. Those who exhibit serious self-harming or other-harming behaviors that require medical treatment at the investigator's discretion during the screening period
4. Those who have been confirmed to have taken the following drugs within 2 weeks prior to screening or are expected to take the following drugs during the human application test period. However, for drugs with a sufficient washout period exceeding 2 weeks, a washout period of at least 5 times the maximum half-life must be confirmed before the screening time.

   ① Antipsychotic drugs (antipsychotic, psychostimulant, antidepressant, anxiolytic, mood stabilizer, and neuroleptic agents). If there is no change in the type or dosage of the drug within 3 months of screening due to long-term use, participation is possible at the investigator's discretion

   ② Selective Serotonin Reuptake Inhibitor (SSRI)
5. Those with the following test results confirmed during screening

   ① Moderate or higher renal impairment (eGFR \<60mL/min/1.73m2)

   ② Moderate or higher hepatic impairment(AST or ALT \>3 x ULN)
6. Those who cannot receive intravenous injection for blood collection
7. Those who have difficulty consuming human application test food or are sensitive or allergic to human test food
8. Those who participated in other clinical trials or human trials within 4 weeks prior to screening and were administered or consumed clinical trial drugs or human test food or were applied with clinical trial medical devices
9. Those who are judged unsuitable for participation in human trials by the investigator

\[baseline visit (Visit 2)\]

1. Those with unsuitable items when reconfirming the selection/exclusion criteria at the time of randomization
2. Those judged unsuitable for participation in this human study by the investigator other than the above

Primary outcomes:
measure: Change rate of major symptoms of autism spectrum disorder (%)_Korean version of Vineland Adaptive Behavior Scale-II(K-VABS-II)
timeFrame: Baseline(0 weeks), 12 weeks
Secondary outcomes:
measure: Social Skills Change Rate (%)_Korean version of Autism Diagnostic Observation Schedule version 2(K-ADOS-2)
timeFrame: Baseline(0 weeks), 12 weeks
measure: Social Skills Change Rate (%)_Korean version of Childhood Autism Rating Scale-2(K-CARS-2)
timeFrame: Baseline(0 weeks), 12 weeks
measure: Social Skills Change Rate (%)_Social Responsiveness Scale-2(SRS-2)
timeFrame: Baseline(0 weeks), 12 weeks
measure: Social Skills Change Rate (%)_Korean version of Social Communication Questionnaire(K-SCQ)
timeFrame: Baseline(0 weeks), 12 weeks
measure: Social Skills Change Rate (%)_Aberrant Behavior Checklist-II
timeFrame: Baseline(0 weeks), 12 weeks
measure: Level of functioning Change Rate (%)_Korean version of Wechsler Primary and Preschool Scale Intelligence-Ⅳ(K-WPPSI-Ⅳ)
timeFrame: Baseline(0 weeks), 12 weeks
measure: Level of functioning Change Rate (%)_CGI-S (Clinical Global Impression-Severity)
timeFrame: Baseline(0 weeks), 12 weeks
measure: Level of functioning Change Rate (%)_CGI-I (Clinical Global Impression-Improvement)
timeFrame: 12 weeks
measure: Executive function Change Rate (%)_Children's Color Trail making Test 1&2(CCTT 1&2)
timeFrame: Baseline(0 weeks), 12 weeks
measure: Executive function Change Rate (%)_Stroop Test (Color & word)
timeFrame: Baseline(0 weeks), 12 weeks
measure: Executive function Change Rate (%)_ Advanced Test of Attention(ATA)
timeFrame: Baseline(0 weeks), 12 weeks
measure: Executive function Change Rate (%)_Korean version of ADHD Rating Scale-IV(K-ARS-4)
timeFrame: Baseline(0 weeks), 12 weeks
measure: Sleep disturbance Change Rate (%)_The Korean version of the Children's Sleep Habits Questionnaire
timeFrame: Baseline(0 weeks), 12 weeks
measure: Anxiety Change Rate (%)_Korean version of Child Behavior Checklist (K-CBCL)
timeFrame: Baseline(0 weeks), 12 weeks
measure: Anxiety Change Rate (%)_Korean form of the State and Trait Anxiety Inventory for Children (K-STAIC)
timeFrame: Baseline(0 weeks), 12 weeks
measure: GI trouble Change Rate (%)_Profile Of Toileting Issue (POTI)
timeFrame: Baseline(0 weeks), 12 weeks
measure: Sensory Change Rate (%)_Short Sensory Profile-2 (SSP-2)
timeFrame: Baseline(0 weeks), 12 weeks
measure: Parenting stress change rate (%)_Korean version of Parenting Stress Index Forth edition-Short Form (K-PSI-4-SF)
timeFrame: Baseline(0 weeks), 12 weeks
Other outcomes:
measure: Rate of change in the type and number of intestinal flora etc. through fecal collection and fecal flora analysis (%)
timeFrame: Baseline(0 weeks), 12 weeks
measure: Rate of change in blood biomarker values
timeFrame: Screening visit (-4 weeks) or Baseline(0 weeks), 12 weeks
measure: Blood collection for DNA analysis
timeFrame: Screening visit (-4 weeks) or Baseline(0 weeks)
measure: Collecting and analyzing information on microorganisms (DNA type, etc.) in the oral cavity by collecting oral samples (such as saliva)
timeFrame: Screening visit (-4 weeks) or Baseline(0 weeks), 12 weeks
Locations:
city: Cheonan
country: Korea, Republic of
facility: Soonchunhyang university hospital cheonan
state: Chungcheongnam-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul national University buseoul national University bundang hospitalndang hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Medical Center
state: Kyungheedae-ro, Dongdaemun-gu
Study officials:
affiliation: Kyunghee University Medical Center
name: Miae OH
role: PRINCIPAL_INVESTIGATOR
References: