Status:
RECRUITING
Effects of Lactobacillus Plantarum PS128 in Children With ASD
Lead Sponsor:
Chang Gung Memorial Hospital
Collaborating Sponsors:
Bened Biomedical Co., Ltd.
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
7-12 years
Phase:
NA
Brief Summary
Autism spectrum disorder (ASD) is a neurodevelopmental disorder that can cause significant social, communication and behavioral deficits. Probiotics are regarded as active microorganisms. With suffici...
Eligibility Criteria
Inclusion
- (1) Age 7 to 12 years old.
- (2) PS128 group and placebo group: Children with autism spectrum disorder, confirmed by Autism Diagnostic Observation Schedule.
- (3) Normal control group: Children without autism spectrum disorder.
Exclusion
- (1) Receiving antibiotics within one month.
- (2) Probiotics used in powder, capsule, or tablet in two weeks (except for Yogurt, Yogurt, Yakult and other related foods).
- (3) Patients with hepatobiliary gastrointestinal tract who have undergone surgery (except for hernia surgery and appendectomy)
- (4) Those with special diets (gluten-free, casein-free, high-protein, and ketogenic diet).
- (5) Those with a history of cancer.
- (6) Those who are allergic to lactic acid bacteria.
- (7) Not eligible judged by PI
Key Trial Info
Start Date :
July 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05307744
Start Date
July 15 2022
End Date
December 31 2026
Last Update
August 31 2023
Active Locations (1)
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1
Chang Gung Memorial Hospital
Taoyuan District, Taiwan