Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06650644
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-17
Brief Title:
A Study to Evaluate the Efficacy and Safety of Lactococcus Lactis KD10 Powder for Improving Autism Spectrum Symptoms in Children with Autism Spectrum Symptoms
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None