Effects Of Lactobacillus Plantarum Ps128 On Children With Autism Spectrum Disorder In Taiwan

Introduction:

At Philadelphia Integrative Psychiatry, we prioritize every aspect of your life and consider your unique history. Our team of mental health professionals and nutritionists brings diverse backgrounds, education, and emphasis to provide you with personalized care. With a commitment to understanding your physical health needs and mental health goals, we go beyond conventional approaches to offer integrative solutions.

Autism Spectrum Disorder is characterized by deficits in social communication, restricted patterns of behaviors. Prevalence is increasing, affecting various facets of life. Mainstream interventions involve psychosocial strategies, with limited evidence supporting dietary and nutritional supplements. Gut-brain axis modulation is linked to improvements in stress responses and behaviors. PS128, a psychobiotic, may impact neurotransmitters and have potential benefits for ASD symptoms.

Abstract:

1. Four-week, randomized, double-blind, placebo-controlled study on boys (7–15 years) with Autism Spectrum Disorder (ASD) in Taiwan.

2. Diagnosis based on DSM-V and Autism Diagnostic Interview-Revised (ADI-R) criteria. Primary outcomes measured by Autism Behavior Checklist-Taiwan version (ABC-T), Social Responsiveness Scale (SRS), and Child Behavior Checklist (CBCL).

3. Secondary outcomes measured by Swanson, Nolan, and Pelham-IV-Taiwan version (SNAP-IV) and Clinical Global Impression-improvement (CGI-I).

4. PS128 showed improvement in opposition/defiance behaviors, significant improvement in total SNAP-IV scores for younger children (7−12 years).

5. Further studies needed for broader understanding of PS128 effects on younger children with ASD.

Materials and Methods:

1. PS128: Lactobacillus plantarum, isolated from spontaneously fermented mustard in Taiwan.

2. Study design: Double-blind, randomized, parallel, placebo-controlled with 80 subjects.

3. Inclusion criteria: Boys aged 7–15 with ASD; exclusion criteria: Recent antibiotics or probiotic consumption.

4. Primary outcomes measured by validated questionnaires: ABC-T, SRS, CBCL; secondary outcomes by SNAP-IV and CGI-I.

5. Two visits: Baseline (randomization, assessments) and Week 4 (medical history review, adverse events).

6. Diagnosis confirmed using Autism Diagnostic Interview-Revised (ADI-R).

Analyses:

1. Clinical assessments: ABC-T, SRS, CBCL, SNAP-IV, and CGI-I.

2. Stratification by age (7–12 and 13–15 years) for exploratory analysis.

3. Statistical analysis using t-tests for demographics, clinical characteristics, and outcome scores.

4. Paired t-tests for within-group analysis. Significance level: P < 0.05.

Results:

1. PS128 showed improvement in opposition/defiance behaviors.

2. Significant improvement in total SNAP-IV scores for younger children (7−12 years). Further studies needed for broader understanding of PS128 effects on younger children with ASD.

Baseline Demographics:

1. Random assignment of 80 subjects (39 PS128, 41 placebo) aged 7–15 for a four-week study.

2. Dropouts: 3 in PS128, 6 in placebo; 71 subjects completed (PS128: 36, placebo: 35).

3. No adverse events reported; no gastrointestinal intolerance or allergic responses.

4. No significant differences in age, height, weight, ASD diagnosis criteria (ADI-R), and CGI-S scores at baseline.

Outcomes Measurement:

1. CGI-I: Both groups showed equivalent "minimally improved" CGI-I scores at week 4 (PS128: 3.64, placebo: 3.66).

2. ABC-T: No significant differences in total ABC-T scores or subscales between PS128 and placebo at baseline and week 4. PS128 showed a trend in reducing scores for body and object use (P = 0.04) in the exploratory analysis.

3. SRS: Similar total and subscale scores between PS128 and placebo at baseline and week 4. Nominal reduction in SRS total score for PS128 group (P = 0.04) in exploratory analysis.

4. CBCL: No significant differences in total CBCL scores between PS128 and placebo at baseline and week 4. PS128 nominally reduced scores for anxiety (P = 0.02) and rule-breaking behaviors (P = 0.02) in exploratory analysis.

5. SNAP-IV: Similar scores between PS128 and placebo at baseline and week 4. Exploratory analysis showed reduced total scores (P = 0.01), hyperactivity/impulsivity (P = 0.04), and opposition/defiance (P = 0.045) in PS128 group.

6. Analysis Stratified by Age: Younger subjects (7–12 years) in PS128 group showed greater benefits in SNAP-IV opposition/defiance and total score. Improvements in CBCL-anxiety, CBCL-rule breaking behavior, SNAP-IV-inattention, hyperactivity/impulsivity, opposition/defiance, and total score in PS128 group (P < 0.05).

Discussion:

Study on the effects of psychobiotic PS128 on ASD behaviors in boys (7–15) in Taiwan. Similar baseline severity and improvement at week 4 in CGI-S and CGI-I scores for both groups. Nominal improvements in various elements for PS128 group, especially younger subjects. PS128 may benefit children with ASD, with potentially greater benefits upon early intervention. High placebo effect observed; longer study duration and objective measurements suggested for future research.

Conclusion:

PS128 demonstrated positive effects on opposition/defiance behaviors and SNAP-IV scores in younger children with ASD. Supports the potential role of psychobiotics in addressing ASD symptoms. Calls for further research to elucidate PS128 effects on ASD in diverse age groups and symptoms.

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