Actively Recruiting
Effects of Lactobacillus Plantarum PS128 in Children With ASD
Led by Chang Gung Memorial Hospital · Updated on 2023-08-31
120
Participants Needed
1
Research Sites
232 weeks
Total Duration
On this page
Sponsors
C
Chang Gung Memorial Hospital
Lead Sponsor
B
Bened Biomedical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Autism spectrum disorder (ASD) is a neurodevelopmental disorder that can cause significant social, communication and behavioral deficits. Probiotics are regarded as active microorganisms. With sufficient amounts, probiotics can regulate intestinal flora, intestinal permeability, inflammation and antioxidant reactions in the body. These reactions may further promote health, regulate metabolic disease progression and prevent complications. Lactobacillus plantarum PS128 (PS128) was reported to be a psychobiotic in several animal and human studies which modulated the levels of neurotransmitters in different brain areas. This study is to evaluate whether the consumption of PS128 can improve the symptoms of patients with ASD. The current randomized, placebo-controlled trial was conducted to investigate the psychophysiological effects of PS128 in school children with ASD.
CONDITIONS
Official Title
Effects of Lactobacillus Plantarum PS128 in Children With ASD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 7 to 12 years old
- Children with autism spectrum disorder confirmed by Autism Diagnostic Observation Schedule for PS128 and placebo groups
- Children without autism spectrum disorder for the normal control group
You will not qualify if you...
- Receiving antibiotics within one month
- Use of probiotics in powder, capsule, or tablet form in the last two weeks (except yogurt and related foods)
- History of hepatobiliary or gastrointestinal surgery (except hernia surgery and appendectomy)
- Following special diets such as gluten-free, casein-free, high-protein, or ketogenic
- History of cancer
- Allergy to lactic acid bacteria
- Not eligible as judged by the principal investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Chang Gung Memorial Hospital
Taoyuan, Taiwan
Actively Recruiting
Research Team
H
Hsing-Chang Ni, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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