Effects of Lactobacillus Plantarum PS128 in Children With ASD

Chang Gung Medical Foundation

Status: Enrolling

Conditions: Autism Spectrum Disorder

Treatments: Dietary Supplement: PS128; Other: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05307744

202101416A3

Details and patient eligibility

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 7 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 3 patient groups, including a placebo group

PS128

Experimental group

Description:

Subjects will take PS128 capsules every day (2 capsules/day, once) for 12 weeks.

Treatment:

Dietary Supplement: PS128

Placebo

Placebo Comparator group

Description:

Subjects will take placebo capsules every day (2 capsules/day, once) for 12 weeks.

Treatment:

Other: Placebo

Normal control

No Intervention group

Description:

Normal control group are enrolled by invitation from the age and gender matched healthy children.