A Study to Evaluate the Efficacy and Safety of Lactococcus Lactis KD10 Powder for Improving Autism Spectrum Symptoms in Children With Autism Spectrum Symptoms.

NCT06650644 | Completed

• 2 other identifiers: KD1020023378
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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.

Conditions

Autism Spectrum Disorder

Keywords

Autism spectrum disorder; Lactococcus lactis; Human Study

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline(0 weeks), 12 weeks

Secondary Outcomes (18)

• Social Skills Change Rate (%)_Korean version of Autism Diagnostic Observation Schedule version 2(K-ADOS-2)

  Baseline(0 weeks), 12 weeks

• Social Skills Change Rate (%)_Korean version of Childhood Autism Rating Scale-2(K-CARS-2)

  Baseline(0 weeks), 12 weeks

• Social Skills Change Rate (%)_Social Responsiveness Scale-2(SRS-2)

  Baseline(0 weeks), 12 weeks

• Social Skills Change Rate (%)_Korean version of Social Communication Questionnaire(K-SCQ)

  Baseline(0 weeks), 12 weeks

• Social Skills Change Rate (%)_Aberrant Behavior Checklist-II

  Baseline(0 weeks), 12 weeks

Other Outcomes (4)

• Rate of change in the type and number of intestinal flora etc. through fecal collection and fecal flora analysis (%)

  Baseline(0 weeks), 12 weeks

• Rate of change in blood biomarker values

  Screening visit (-4 weeks) or Baseline(0 weeks), 12 weeks

• Blood collection for DNA analysis

  Screening visit (-4 weeks) or Baseline(0 weeks)

Study Arms (2)

Test food group

EXPERIMENTAL

Food name: Lactococcus lactis KD10

Dietary Supplement: Lactococcus lactis KD10 (health food)

Control food group

PLACEBO COMPARATOR

Food name: Placebo of Lactococcus lactis KD10

Other: Placebo of Lactococcus lactis KD10

Interventions

Placebo of Lactococcus lactis KD10 OTHER

* 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

Control food group

Lactococcus lactis KD10 (health food) DIETARY_SUPPLEMENT

* 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

Test food group

Eligibility Criteria

• Age: 36 Months - 91 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 3 years or older and 7 years and 7 months or younger
• 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.)
• 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
• 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
• 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.

You may not qualify if:

• \[Screening Visit (Visit 1)\]
• 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
• Those with uncontrolled medical conditions (including arrhythmia, cancer, severe heart/kidney disease) during the screening period
• Those who exhibit serious self-harming or other-harming behaviors that require medical treatment at the investigator's discretion during the screening period
• 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)
• 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)
• Those who cannot receive intravenous injection for blood collection

Sponsors & Collaborators

• Miae Oh: lead
• KoBioLabs: collaborator
• Korea University: collaborator

Study Sites (2)

Seoul national University buseoul national University bundang hospitalndang hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Kyung Hee University Medical Center

Seoul, Kyungheedae-ro, Dongdaemun-gu, 02447, South Korea

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Miae OH

  Kyunghee University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 21, 2024
• Study Start: October 10, 2024
• Primary Completion: July 23, 2025
• Study Completion: July 23, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

KR (2)