Effects of Lactobacillus Plantarum PS128 in Children With ASD

NCT05307744 | Recruiting

• 1 other identifier: 202101416A3
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• Changes of total scores of Social Responsiveness Scale

  Social Responsiveness Scale can measure the autism clinical severity with the range from 65-260. The lower scores stand for better social responsiveness.

  Baseline, Week 12 and Week 16

Secondary Outcomes (33)

• Changes of total scores of Repetitive Behavior Scale-Revised

  Baseline, Week 12 and Week 16

• Changes of total scores of Child Behavior Checklist

  Baseline, Week 12 and Week 16

• Changes of total scores of Adaptive Behavior Assessment System

  Baseline, week 12 and Week 16W

• Changes in accuracy of Frith-Happe animation

  Baseline, Week 12 and Week 16

• Changes in accuracy of Eyes task

  Baseline, Week 12 and Week 16

Study Arms (3)

PS128

EXPERIMENTAL

Subjects will take PS128 capsules every day (2 capsules/day, once) for 12 weeks.

Dietary Supplement: PS128

Placebo

PLACEBO COMPARATOR

Subjects will take placebo capsules every day (2 capsules/day, once) for 12 weeks.

Other: Placebo

Normal control

NO INTERVENTION

Normal control group are enrolled by invitation from the age and gender matched healthy children.

Interventions

PS128 DIETARY_SUPPLEMENT

Each PS128 capsule contained \>3 × 10\^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg.

PS128

Placebo OTHER

The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose.

Placebo

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• (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.

You may not qualify if:

• (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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• Bened Biomedical Co., Ltd.: collaborator

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Taiwan

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Hsing-Chang Ni, Dr.

CONTACT

88633281200; alanni0918@yahoo.com.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: April 1, 2022
• Study Start: July 15, 2022
• Primary Completion: July 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 31, 2023

Record last verified: 2023-08

Locations

TW (1)