CompletedNot Applicable

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

South Korea48 participantsStarted 2024-10-10

Plain-language 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.

Who can participate

Age range

36 Months – 91 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT06650644

SponsorMiae Oh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-23

View on ClinicalTrials.gov More Autism Spectrum Disorder trials