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Recruiting NCT05307744

Effects of Lactobacillus Plantarum PS128 in Children With ASD

No phase Interventional Autism Spectrum Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PS128, Placebo.
Who it may be relevant to
Registry conditions: Autism Spectrum Disorder. Basic parameters: 7 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effects of Lactobacillus Plantarum PS128 in Children With Autism Spectrum Disorder

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Changes of total scores of Social Responsiveness Scale [Time frame: Baseline, Week 12 and Week 16]
Secondary outcome measures (12)
  • Changes of total scores of Repetitive Behavior Scale-Revised [Time frame: Baseline, Week 12 and Week 16]
  • Changes of total scores of Child Behavior Checklist [Time frame: Baseline, Week 12 and Week 16]
  • Changes of total scores of Adaptive Behavior Assessment System [Time frame: Baseline, week 12 and Week 16W]
  • Changes in accuracy of Frith-Happe animation [Time frame: Baseline, Week 12 and Week 16]
  • Changes in accuracy of Eyes task [Time frame: Baseline, Week 12 and Week 16]
  • Changes of total scores of Aberrant Behavior Checklist [Time frame: Baseline, Week 12 and Week 16]
  • Visual Analogue Scale for GI symptoms [Time frame: Baseline, week 12 and Week 16]
  • Changes of total scores of Emotional Dysregulation Inventory [Time frame: Baseline, Week 12 and Week 16]
  • Changes of total scores of Parenting Stress Index, Fourth Editon [Time frame: Baseline, Week 12 and Week 16]
  • Assessment of Clinical Global Impression-Severity of Illness [Time frame: Baseline, Week 12 and Week 16]
  • Assessment of Patient Global Impression of Change [Time frame: Week 12 and Week 16]
  • Gut microbiota [Time frame: Baseline and Week 12]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Other

Study locations

Taiwan · 1 center
  • Chang Gung Memorial Hospital — Taoyuan

Identifiers

NCT: NCT05307744 · 202101416A3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗