Trials / Completed
CompletedNCT06650644
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 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.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Miae Oh · Academic / Other
- Sex
- All
- Age
- 36 Months – 91 Months
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | 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 |
| DIETARY_SUPPLEMENT | 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 |
Timeline
- Start date
- 2024-10-10
- Primary completion
- 2025-07-23
- Completion
- 2025-07-23
- First posted
- 2024-10-21
- Last updated
- 2025-08-22
Locations
2 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT06650644. Inclusion in this directory is not an endorsement.