Effects of Lactobacillus Plantarum PS128 on children with autism
Effects of Lactobacillus Plantarum PS128 in Children With Autism Spectrum Disorder
NA · Chang Gung Memorial Hospital · NCT05307744
This study is testing if a probiotic called Lactobacillus plantarum PS128 can help improve symptoms in children with autism aged 7 to 12.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 7 Years to 12 Years |
| Sex | All |
| Sponsor | Chang Gung Memorial Hospital (other) |
| Locations | 1 site (Taoyuan) |
| Trial ID | NCT05307744 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the impact of Lactobacillus plantarum PS128, a type of probiotic, on children diagnosed with Autism Spectrum Disorder (ASD). The study is designed as a randomized, placebo-controlled trial, where participants aged 7 to 12 years will receive either the probiotic or a placebo to assess improvements in ASD symptoms. The research aims to explore the psychophysiological effects of PS128, which has shown potential in modulating neurotransmitter levels in previous studies. By investigating these effects, the trial seeks to determine if this probiotic can enhance the quality of life for children with ASD.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 7 to 12 years with a confirmed diagnosis of autism spectrum disorder.
Not a fit: Patients who have received antibiotics within the last month or those with specific dietary restrictions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel therapeutic option for improving symptoms in children with autism spectrum disorder.
How similar studies have performed: Previous studies have indicated potential benefits of probiotics in modulating symptoms of autism, suggesting this approach may be promising.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Taoyuan
- Chang Gung Memorial Hospital — Taoyuan, Taiwan (RECRUITING)
Study contacts
- Study coordinator: Hsing-Chang Ni, Dr.
- Email: alanni0918@yahoo.com.tw
- Phone: 88633281200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Autism Spectrum Disorder