Effects of Lactobacillus Plantarum PS128 in Children With ASD
- Conditions
- Autism Spectrum Disorder
- Interventions
- Dietary Supplement: PS128Other: Placebo
- Registration Number
- NCT05307744
- Lead Sponsor
- Chang Gung Memorial Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- (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.
- (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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PS128 PS128 Subjects will take PS128 capsules every day (2 capsules/day, once) for 12 weeks. Placebo Placebo Subjects will take placebo capsules every day (2 capsules/day, once) for 12 weeks.
- Primary Outcome Measures
Name Time Method Changes of total scores of Social Responsiveness Scale 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 Outcome Measures
Name Time Method Changes of total scores of Child Behavior Checklist 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.
Changes of total scores of Adaptive Behavior Assessment System 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.
Changes in accuracy of Eyes task 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.
Changes of total scores of Aberrant Behavior Checklist 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.
Safety assessment - Uric Acid Baseline and Week 12 Safety is assessed function of liver and kidney such as uric acid (3.4-7.6 mg/dl).
Change in levels of exploratory blood-based biomarkers for inflammatory changes - IL-1β Baseline and Week 12 Inflammatory is assessed via a composite measure of circulating cytokines - IL-1β (pg/mL)
Changes in accuracy of Frith-Happe animation 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.
Changes of total scores of Parenting Stress Index, Fourth Editon 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.
Assessment of Clinical Global Impression-Severity of Illness 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.
Diffusion Tensor Imaging (DTI) - FA 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.
Safety assessment - Total Protein Baseline and Week 12 Safety is assessed function of liver and kidney such as total protein (3.8-5.3 g/dl).
Safety assessment - ALP Baseline and Week 12 Safety is assessed function of liver and kidney such as ALP (40-129 IU/L).
Changes of total scores of Repetitive Behavior Scale-Revised 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.
Gut microbiota 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.
Safety assessment - Creatinine Baseline and Week 12 Safety is assessed function of liver and kidney such as creatinine (0.6-1.3 mg/dl).
Safety assessment - AST Baseline and Week 12 Safety is assessed function of liver and kidney such as AST (8-38 IU/L).
Change in levels of exploratory blood-based biomarkers for inflammatory changes - Eotaxin Baseline and Week 12 Inflammatory is assessed via a composite measure of circulating cytokines - Eotaxin (pg/mL)
Change in levels of exploratory blood-based biomarkers for inflammatory changes - IL-6 Baseline and Week 12 Inflammatory is assessed via a composite measure of circulating cytokines - IL-6 (ng/mL)
Change in levels of exploratory blood-based biomarkers for oxidative stress changes - GABA Baseline and Week 12 Oxidative stress is assessed via GABA (umol/L).
Visual Analogue Scale for GI symptoms 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.
Safety assessment - Total Bilirubin Baseline and Week 12 Safety is assessed function of liver and kidney such as total bilirubin (0.2-1.2 mg/dl).
Changes of total scores of Emotional Dysregulation Inventory 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.
Assessment of Patient Global Impression of Change 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."
MRI T1 Baseline and Week 12 Brain structural volumes (cm²)
functional MRI (resting-state/biological motion task) - BOLD signal Baseline and Week 12 Blood-oxygen-level-dependent (BOLD) signal is a measurement used in fMRI, which reflects the neural activity.
Safety assessment - Albumin Baseline and Week 12 Safety is assessed function of liver and kidney such as albumin (6.6-8.7 g/dl).
Safety assessment - T-Cholesterol Baseline and Week 12 Safety is assessed function of liver and kidney such as T-Cholesterol (\<170 mg/dL).
Safety assessment - BUN Baseline and Week 12 Safety is assessed function of liver and kidney such as BUN (6-20 mg/dl).
Safety assessment - ALT Baseline and Week 12 Safety is assessed function of liver and kidney such as ALT (4-44 IU/L).
Change in levels of exploratory blood-based biomarkers for inflammatory changes - MPO Baseline and Week 12 Inflammatory is assessed via a composite measure of circulating cytokines - MPO (ng/mL)
Change in levels of exploratory blood-based biomarkers for inflammatory changes - TGF-β1 Baseline and Week 12 Inflammatory is assessed via a composite measure of circulating cytokines - TGF-β1 (pg/mL)
Change in levels of exploratory blood-based biomarkers for oxidative stress changes - Serotonin Baseline and Week 12 Oxidative stress is assessed via Serotonin (ng/mL).
Change in levels of exploratory blood-based biomarkers for oxidative stress changes - Cortisol Baseline and Week 12 Oxidative stress is assessed via Cortisol (nmol/L).
Trial Locations
- Locations (1)
Chang Gung Memorial Hospital
🇨🇳Taoyuan, Taiwan