NCT05307744 Effects of Lactobacillus Plantarum PS128 in Children With ASD
| NCT ID | NCT05307744 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chang Gung Memorial Hospital |
| Condition | Autism Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2022-07-15 |
| Primary Completion | 2025-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2022-07-15 with a primary completion date of 2025-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05307744 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, up to 12 Years, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05307744 currently recruiting?
Yes, NCT05307744 is actively recruiting participants. Contact the research team at alanni0918@yahoo.com.tw for enrollment information.
Where is the NCT05307744 trial being conducted?
This trial is being conducted at Taoyuan, Taiwan.
Who is sponsoring the NCT05307744 clinical trial?
NCT05307744 is sponsored by Chang Gung Memorial Hospital. The trial plans to enroll 120 participants.