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Effects of Lactobacillus Plantarum PS128 in Children With ASD

NCT05307744 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-08-31

No results posted yet for this 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.

Conditions

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.

Sponsors & Collaborators

  • Bened Biomedical Co., Ltd.

    collaborator INDUSTRY

  • Chang Gung Memorial Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-15
Primary Completion
2025-07-31
Completion
2026-12-31

Countries

  • Taiwan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05307744 on ClinicalTrials.gov