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NCT Number: NCT05307744

Effects of Lactobacillus Plantarum PS128 in Children With ASD

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.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital

Taoyuan, Taiwan

Location status: Recruiting

Location contact

Hsing Chang Ni

CONTACT

[email protected]

886-3-3281200 ext. 2479

Hsing Chang Ni, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PS128

Dietary Supplement

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

Placebo

Other

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

Primary outcomes

  1. Changes of total scores of Social Responsiveness Scale

    Time frame: Baseline, Week 12 and Week 16

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

Secondary outcomes

  1. Changes of total scores of Repetitive Behavior Scale-Revised

    Time frame: Baseline, Week 12 and Week 16

    Repetitive Behavior Scale-Revised is a questionnaire that focuses on repetitive behavior. The score ranges from 0-129. The lower scores stand for lower repetitive behavior.

  2. Changes of total scores of Child Behavior Checklist

    Time frame: Baseline, Week 12 and Week 16

    Child Behavior Checklist is a parents' report questionnaire for behavioral and emotional problems. The lower scores stand for better behavioral and emotional regulation.

  3. Changes of total scores of Adaptive Behavior Assessment System

    Time frame: Baseline, week 12 and Week 16W

    Adaptive Behavior Assessment System is a parents' report questionnaire for adaptive behavior. The score ranges from 9-171. The higher scores stand for better adaptive behavior.

  4. Changes in accuracy of Frith-Happe animation

    Time frame: Baseline, Week 12 and Week 16

    A quick and objective test of Theory of Mind. 8 questions in total, the more correct questions stand for better Social Cognition.

  5. Changes in accuracy of Eyes task

    Time frame: Baseline, Week 12 and Week 16

    An advanced test for Theory of Mind. 43 questions in total, the more correct questions stand for better social skills.

  6. Changes of total scores of Aberrant Behavior Checklist

    Time frame: Baseline, Week 12 and Week 16

    Aberrant Behavior Checklist is a parents' report questionnaire for aberrant behavior. The lower scores stand for less aberrant behavior.

  7. Visual Analogue Scale for GI symptoms

    Time frame: Baseline, week 12 and Week 16

    Visual Analogue Scale for GI symptoms was designed to measure the response of symptoms and well-being in patients after taking PS128. The score ranges from 0-10. The lower scores stand for less GI symptoms.

  8. Changes of total scores of Emotional Dysregulation Inventory

    Time frame: Baseline, Week 12 and Week 16

    Emotional Dysregulation Inventory is a parents' report questionnaire for emotional dysregulation. The score ranges from 0-120. The lower scores stand for better emotional regulation.

  9. Changes of total scores of Parenting Stress Index, Fourth Editon

    Time frame: Baseline, Week 12 and Week 16

    Parenting Stress Index is a parents' report questionnaire for parenting stress. The lower scores stand for lower parenting stress.

  10. Assessment of Clinical Global Impression-Severity of Illness

    Time frame: Baseline, Week 12 and Week 16

    The Clinical Global Impression (CGI) is a clinician rated measure of illness severity, improvement, and efficacy of treatment. The CGI-I is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.CGI Improvement scale: 1=very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; 7=Very much worse.

  11. Assessment of Patient Global Impression of Change

    Time frame: Week 12 and Week 16

    The self-report measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment. PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."

  12. Gut microbiota

    Time frame: Baseline and Week 12

    Collect the DNA of fecal flora to test the diversity and abundance of gut microbiota as well as short chain fatty acids in Stool samples. The 16S rRNA gene amplicons will be prepared following the Illumina protocol for preparing the 16S metagenomic sequencing library.

  13. MRI T1

    Time frame: Baseline and Week 12

    Brain structural volumes (cm²)

  14. functional MRI (resting-state/biological motion task) - BOLD signal

    Time frame: Baseline and Week 12

    Blood-oxygen-level-dependent (BOLD) signal is a measurement used in fMRI, which reflects the neural activity.

  15. Diffusion Tensor Imaging (DTI) - FA

    Time frame: Baseline and Week 12

    Fractional anisotropy (FA) is a measurement used in DTI, which reflects the movement of water molecules. FA ranges from 0 to 1, the higher FA value may represent more intact axons.

  16. Safety assessment - Albumin

    Time frame: Baseline and Week 12

    Safety is assessed function of liver and kidney such as albumin (6.6-8.7 g/dl).

  17. Safety assessment - Total Protein

    Time frame: Baseline and Week 12

    Safety is assessed function of liver and kidney such as total protein (3.8-5.3 g/dl).

  18. Safety assessment - ALP

    Time frame: Baseline and Week 12

    Safety is assessed function of liver and kidney such as ALP (40-129 IU/L).

  19. Safety assessment - Total Bilirubin

    Time frame: Baseline and Week 12

    Safety is assessed function of liver and kidney such as total bilirubin (0.2-1.2 mg/dl).

  20. Safety assessment - T-Cholesterol

    Time frame: Baseline and Week 12

    Safety is assessed function of liver and kidney such as T-Cholesterol (<170 mg/dL).

  21. Safety assessment - Uric Acid

    Time frame: Baseline and Week 12

    Safety is assessed function of liver and kidney such as uric acid (3.4-7.6 mg/dl).

  22. Safety assessment - BUN

    Time frame: Baseline and Week 12

    Safety is assessed function of liver and kidney such as BUN (6-20 mg/dl).

  23. Safety assessment - Creatinine

    Time frame: Baseline and Week 12

    Safety is assessed function of liver and kidney such as creatinine (0.6-1.3 mg/dl).

  24. Safety assessment - AST

    Time frame: Baseline and Week 12

    Safety is assessed function of liver and kidney such as AST (8-38 IU/L).

  25. Safety assessment - ALT

    Time frame: Baseline and Week 12

    Safety is assessed function of liver and kidney such as ALT (4-44 IU/L).

  26. Change in levels of exploratory blood-based biomarkers for inflammatory changes - MPO

    Time frame: Baseline and Week 12

    Inflammatory is assessed via a composite measure of circulating cytokines - MPO (ng/mL)

  27. Change in levels of exploratory blood-based biomarkers for inflammatory changes - IL-1β

    Time frame: Baseline and Week 12

    Inflammatory is assessed via a composite measure of circulating cytokines - IL-1β (pg/mL)

  28. Change in levels of exploratory blood-based biomarkers for inflammatory changes - TGF-β1

    Time frame: Baseline and Week 12

    Inflammatory is assessed via a composite measure of circulating cytokines - TGF-β1 (pg/mL)

  29. Change in levels of exploratory blood-based biomarkers for inflammatory changes - Eotaxin

    Time frame: Baseline and Week 12

    Inflammatory is assessed via a composite measure of circulating cytokines - Eotaxin (pg/mL)

  30. Change in levels of exploratory blood-based biomarkers for inflammatory changes - IL-6

    Time frame: Baseline and Week 12

    Inflammatory is assessed via a composite measure of circulating cytokines - IL-6 (ng/mL)

  31. Change in levels of exploratory blood-based biomarkers for oxidative stress changes - Serotonin

    Time frame: Baseline and Week 12

    Oxidative stress is assessed via Serotonin (ng/mL).

  32. Change in levels of exploratory blood-based biomarkers for oxidative stress changes - GABA

    Time frame: Baseline and Week 12

    Oxidative stress is assessed via GABA (umol/L).

  33. Change in levels of exploratory blood-based biomarkers for oxidative stress changes - Cortisol

    Time frame: Baseline and Week 12

    Oxidative stress is assessed via Cortisol (nmol/L).

Study contacts

Contact information is provided by the study sponsor or research team.

Hsing-Chang Ni, Dr.

CONTACT

[email protected]

88633281200 ext. 3815

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Collaborators

  • Bened Biomedical Co., Ltd.

Registry information

Official study title

Effects of Lactobacillus Plantarum PS128 in Children With Autism Spectrum Disorder

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Apr 1, 2022
Registry last updated
Aug 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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