NCT05307744Terminated
Effects of Lactobacillus Plantarum PS128 in Children With ASD
Effects of Lactobacillus Plantarum PS128 in Children With Autism Spectrum Disorder
Source: ClinicalTrials.gov · Last updated 6 Oct 2026
Reason given: During COVID-19, study execution and participant compliance were significantly impacted. Lengthy procedures reduced parental and child willingness, causing slow recruitment. Due to these operational challenges, the study was terminated early.
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Study type
- Interventional
- Enrollment
- 41 (actual)
- First submitted
- 14 Mar 2022
- Start date
- 15 Jul 2022
- Primary completion date
- 3 Apr 2024
- Lead sponsor
- Chang Gung Memorial Hospital
- Diseases
- Autism
- NCT number
- NCT05307744
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- (1) Receiving antibiotics within one month.
- (3) Patients with hepatobiliary gastrointestinal tract who have undergone surgery (except for hernia surgery and appendectomy)
Other illness
- (5) Those with a history of cancer.
- (6) Those who are allergic to lactic acid bacteria.
Other
- (2) Probiotics used in powder, capsule, or tablet in two weeks (except for Yogurt, Yogurt, Yakult and other related foods).
- (4) Those with special diets (gluten-free, casein-free, high-protein, and ketogenic diet).
- (7) Not eligible judged by PI
Who the study is looking for
- (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.
Age in the registry: 7 years to 12 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chang Gung Memorial Hospital | Taoyuan | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.