Autism Spectrum DisorderNCT06650644
A Study to Evaluate the Efficacy and Safety of Lactococcus Lactis KD10 Powder for Improving Autism Spectrum Symptoms in Children With Autism Spectrum Symptoms.
A study testing Lactococcus lactis KD10 (health food) in people with Autism Spectrum Disorder, run by Miae Oh at 2 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 36 to 91 months
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Lactococcus lactis KD10 (health food)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 10 Oct 2024to 23 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 91 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- [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
Show all 21Show fewer
- 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
- Those who have difficulty consuming human application test food or are sensitive or allergic to human test food
- 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
- Those who are judged unsuitable for participation in human trials by the investigator
- [baseline visit (Visit 2)]
- Those with unsuitable items when reconfirming the selection/exclusion criteria at the time of randomization
- Those judged unsuitable for participation in this human study by the investigator other than the above
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul national University buseoul national University bundang hospitalndang hospital
Seongnam-si, Gyeonggi-do, 13620
Kyung Hee University Medical Center
Seoul, Kyungheedae-ro, Dongdaemun-gu, 02447
About this study
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.
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Placebo of Lactococcus lactis KD10, Lactococcus lactis KD10 (health food)
- Keywords
- Autism spectrum disorder, Lactococcus lactis, Human Study
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo of Lactococcus lactis KD10Other
- 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
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
| Study group | Role | What they receive |
|---|---|---|
| Test food group | Experimental | Food name: Lactococcus lactis KD10 Receives: Dietary Supplement: Lactococcus lactis KD10 (health food) |
| Control food group | Placebo comparator | Food name: Placebo of Lactococcus lactis KD10 Receives: Other: Placebo of Lactococcus lactis KD10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline(0 weeks), 12 weeks
Secondary outcomes (18)
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.
Measured: 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
Measured: 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.
Measured: Baseline(0 weeks), 12 weeks
Social Skills Change Rate (%)_Korean version of Social Communication Questionnaire(K-SCQ)
Questions to screen for Autism Spectrum Disorder.
Measured: Baseline(0 weeks), 12 weeks
Social Skills Change Rate (%)_Aberrant Behavior Checklist-II
Symptom checklist to assess problem behaviors in children with developmental disabilities.
Measured: Baseline(0 weeks), 12 weeks
Level of functioning Change Rate (%)_Korean version of Wechsler Primary and Preschool Scale Intelligence-Ⅳ(K-WPPSI-Ⅳ)
Assess cognitive abilities
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline(0 weeks), 12 weeks
Executive function Change Rate (%)_Stroop Test (Color & word)
Measures attention and response inhibition.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline(0 weeks), 12 weeks
GI trouble Change Rate (%)_Profile Of Toileting Issue (POTI)
A scale to check toilet use problems.
Measured: Baseline(0 weeks), 12 weeks
Sensory Change Rate (%)_Short Sensory Profile-2 (SSP-2)
Measuring children's responses to sensory processing in everyday life.
Measured: 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
Measured: Baseline(0 weeks), 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start10 Oct 2024
- Primary completion23 Jul 2025
- Study completion23 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miae Oh
- Sponsor type
- University, hospital or other
- Collaborators
- KoBioLabs, Korea University
- Responsible party
- Sponsor-investigator, Miae Oh, Kyunghee University Medical Center
- Investigators
- Miae OH, Principal investigator, Kyunghee University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650644
- Sponsor's protocol ID
- KD10
- Other IDs
- 20023378
- Status last verified
- Aug 2025
- First submitted
- 17 Oct 2024
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We plan to share any related individual participant data within reasonable request which can be obtained from the principal investigators.
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06650644
- Acronym / sponsor ID
- KD10
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism spectrum disorder, Lactococcus lactis, Human Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Miae OhUniversity, hospital or other
- Collaborators
- KoBioLabs, Korea University
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 23 Jul 2025 (actual)
- Study completion
- 23 Jul 2025 (actual)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test food group | Experimental | Dietary Supplement: Lactococcus lactis KD10 (health food)Food name: Lactococcus lactis KD10 |
| Control food group | Placebo comparator | Other: Placebo of Lactococcus lactis KD10Food name: Placebo of Lactococcus lactis KD10 |
Who may qualify
- Ages
- 36 to 91 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (21 listed)
- [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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo of Lactococcus lactis KD10* 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 | Other | Control food group |
| Lactococcus lactis KD10 (health food)* 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 | Dietary supplement | Test food group |
Primary outcome
Change rate of major symptoms of autism spectrum disorder (%)_Korean version of Vineland Adaptive Behavior Scale-II(K-VABS-II)
Time frame: Baseline(0 weeks), 12 weeks
To determine the change rate (%) in major symptoms of autism spectrum disorder
18 secondary outcomes
Social Skills Change Rate (%)_Korean version of Autism Diagnostic Observation Schedule version 2(K-ADOS-2)
Time frame: Baseline(0 weeks), 12 weeks
Social Skills Change Rate (%)_Korean version of Childhood Autism Rating Scale-2(K-CARS-2)
Time frame: Baseline(0 weeks), 12 weeks
Social Skills Change Rate (%)_Social Responsiveness Scale-2(SRS-2)
Time frame: Baseline(0 weeks), 12 weeks
Social Skills Change Rate (%)_Korean version of Social Communication Questionnaire(K-SCQ)
Time frame: Baseline(0 weeks), 12 weeks
Social Skills Change Rate (%)_Aberrant Behavior Checklist-II
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)
Time frame: Baseline(0 weeks), 12 weeks
Level of functioning Change Rate (%)_CGI-S (Clinical Global Impression-Severity)
Time frame: Baseline(0 weeks), 12 weeks
Level of functioning Change Rate (%)_CGI-I (Clinical Global Impression-Improvement)
Time frame: 12 weeks
Executive function Change Rate (%)_Children's Color Trail making Test 1&2(CCTT 1&2)
Time frame: Baseline(0 weeks), 12 weeks
Executive function Change Rate (%)_Stroop Test (Color & word)
Time frame: Baseline(0 weeks), 12 weeks
Executive function Change Rate (%)_ Advanced Test of Attention(ATA)
Time frame: Baseline(0 weeks), 12 weeks
Executive function Change Rate (%)_Korean version of ADHD Rating Scale-IV(K-ARS-4)
Time frame: Baseline(0 weeks), 12 weeks
Sleep disturbance Change Rate (%)_The Korean version of the Children's Sleep Habits Questionnaire
Time frame: Baseline(0 weeks), 12 weeks
Anxiety Change Rate (%)_Korean version of Child Behavior Checklist (K-CBCL)
Time frame: Baseline(0 weeks), 12 weeks
Anxiety Change Rate (%)_Korean form of the State and Trait Anxiety Inventory for Children (K-STAIC)
Time frame: Baseline(0 weeks), 12 weeks
GI trouble Change Rate (%)_Profile Of Toileting Issue (POTI)
Time frame: Baseline(0 weeks), 12 weeks
Sensory Change Rate (%)_Short Sensory Profile-2 (SSP-2)
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)
Time frame: Baseline(0 weeks), 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: Undecided. We plan to share any related individual participant data within reasonable request which can be obtained from the principal investigators.
Related trials for Autism Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
Recruiting
Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism
Autism, Autism Spectrum Disorder
Recruiting
Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children With Autism
Autism Spectrum Disorder, Autism
RecruitingPhase 2
A Study of Esomeprazole in Children With Autism
Autism, Autism Spectrum Disorder
Recruiting
Transcranial Magnetic Stimulation for Restricted and Repetitive Behavior in ASD
Autism Spectrum Disorder, Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miae OH principal investigator
Kyunghee University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactococcus lactis KD10 (health food) in people with Autism Spectrum Disorder, run by Miae Oh at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change rate of major symptoms of autism spectrum disorder (%)_Korean version of Vineland Adaptive Behavior Scale-II(K-VABS-II) (time frame: Baseline(0 weeks), 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.