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RECRUITINGINTERVENTIONAL

Effects of Lactobacillus Plantarum PS128 in Children With ASD

Effects of Lactobacillus Plantarum PS128 in Children With Autism Spectrum Disorder

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - (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. Who Should NOT Join This Trial: - (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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * (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 Criteria: * (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

Treatments Being Tested

DIETARY_SUPPLEMENT

PS128

Each PS128 capsule contained \>3 × 10\^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg.

OTHER

Placebo

The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose.

Locations (1)

Chang Gung Memorial Hospital
Taoyuan District, Taiwan