Effects of Lactobacillus Plantarum PS128 in Children With ASD
NCT ID: NCT05307744
Last Updated: 2023-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2022-07-15
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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PS128
Subjects will take PS128 capsules every day (2 capsules/day, once) for 12 weeks.
PS128
Each PS128 capsule contained \>3 × 10\^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg.
Placebo
Subjects will take placebo capsules every day (2 capsules/day, once) for 12 weeks.
Placebo
The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose.
Normal control
Normal control group are enrolled by invitation from the age and gender matched healthy children.
No interventions assigned to this group
Interventions
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PS128
Each PS128 capsule contained \>3 × 10\^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg.
Placebo
The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose.
Eligibility Criteria
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Inclusion Criteria
* (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
* (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
7 Years
12 Years
ALL
Yes
Sponsors
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Bened Biomedical Co., Ltd.
INDUSTRY
Chang Gung Memorial Hospital
OTHER
Responsible Party
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Locations
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Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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202101416A3
Identifier Type: -
Identifier Source: org_study_id
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