Last updated: August 29, 2023
Sponsor: Chang Gung Memorial Hospital
Overall Status: Active - Recruiting
Phase
N/A
Condition
Asperger's Disorder
Williams Syndrome
Treatment
Placebo
PS128
Clinical Study ID
NCT05307744
202101416A3
Ages 7-12 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- (1) Age 7 to 12 years old.
- (2) PS128 group and placebo group: Children with autism spectrum disorder, confirmedby Autism Diagnostic Observation Schedule.
- (3) Normal control group: Children without autism spectrum disorder.
Exclusion
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 ketogenicdiet).
- (5) Those with a history of cancer.
- (6) Those who are allergic to lactic acid bacteria.
- (7) Not eligible judged by PI
Study Design
Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
July 15, 2022
Estimated Completion Date:
December 31, 2026
Connect with a study center
Chang Gung Memorial Hospital
Taoyuan,
TaiwanActive - Recruiting
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