Effects of Lactobacillus Plantarum PS128 in Children With ASD

Last updated: August 29, 2023
Sponsor: Chang Gung Memorial Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Asperger's Disorder

Williams Syndrome

Treatment

Placebo

PS128

Clinical Study ID

NCT05307744
202101416A3
  • Ages 7-12
  • All Genders
  • Accepts Healthy Volunteers

Study 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 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • (1) Age 7 to 12 years old.
  • (2) PS128 group and placebo group: Children with autism spectrum disorder, confirmedby Autism Diagnostic Observation Schedule.
  • (3) Normal control group: Children without autism spectrum disorder.

Exclusion

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 ketogenicdiet).
  • (5) Those with a history of cancer.
  • (6) Those who are allergic to lactic acid bacteria.
  • (7) Not eligible judged by PI

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
July 15, 2022
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Chang Gung Memorial Hospital

    Taoyuan,
    Taiwan

    Active - Recruiting

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