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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 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-08-22

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • KoBioLabs

    collaborator INDUSTRY

  • Korea University

    collaborator OTHER

  • Miae Oh

    lead OTHER

Principal Investigators

  • Miae OH · Kyunghee University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
36 Months
Max Age
91 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-10
Primary Completion
2025-07-23
Completion
2025-07-23

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06650644 on ClinicalTrials.gov