Effects of Lactobacillus Plantarum PS128 in Children With Autism Spectrum Disorder

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 12
Healthy Volunteers: t
View:

• (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.

Locations
Other Locations
Taiwan
Chang Gung Memorial Hospital
RECRUITING
Taoyuan District
Contact Information
Primary
Hsing-Chang Ni, Dr.
alanni0918@yahoo.com.tw
88633281200
Time Frame
Start Date: 2022-07-15
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 120
Treatments
Experimental: PS128
Subjects will take PS128 capsules every day (2 capsules/day, once) for 12 weeks.
Placebo_comparator: Placebo
Subjects will take placebo capsules every day (2 capsules/day, once) for 12 weeks.
No_intervention: Normal control
Normal control group are enrolled by invitation from the age and gender matched healthy children.
Related Therapeutic Areas
Sponsors
Leads: Chang Gung Memorial Hospital
Collaborators: Bened Biomedical Co., Ltd.

This content was sourced from clinicaltrials.gov