Psychophysiological Effects of Lactobacillus Plantarum PS128 in Preschool Children With Autism Spectrum Disorder: a Randomized, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Changes from baseline of anxiety subscale in Children's Behavior Checklist (CBCL)/Achenbach System of Empirically Based Assessment (ASEBA) at week 8 and week 16
研究概览
简要总结
Autism Spectrum Disorders (ASD) comprises a complex group of disorders of neuronal development characterized by social and communication impairment along with presence of repetitive and restrictive behaviors. Emerging evidences support the gut-brain axis and further microbiota-gut-brain axis. Elevated prevalence of gastrointestinal (GI) dysfunction in individuals with ASD suggested that targeting gut may benefit patients with ASD. Lactobacillus plantarum PS128 (PS128) was reported to be a psychobiotic in several animal studies which modulated the levels of neurotransmitters in different brain areas. The current randomized, placebo-controlled trial was conducted to investigate the psychophysiological effects of PS128 in preschool children with ASD.
详细描述
Emerging evidences support the gut-brain axis and further microbiota-gut-brain axis. Elevated prevalence of gastrointestinal (GI) dysfunction in individuals with ASD suggested that targeting gut may benefit patients with ASD. Lactobacillus plantarum PS128 (PS128) was reported to be a psychobiotic in several animal studies which modulated the levels of neurotransmitters in different brain areas. The current randomized, placebo-controlled trial was conducted to investigate the psychophysiological effects of PS128 in preschool children with ASD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Investigators, researchers, outcome assessors, subjects and caregivers will be blinded to the randomization. A research assistant who is not involved in this trial will do the randomization by using randomly permuted blocks within the strata of two assignments, the placebo group and PS128 group with the ratio of 1:1.
入排标准
- 年龄范围
- 30 Months 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fulfill Diagnostic and Statistical Manual of Mental Disorders fifth version (DSM-V) criteria of Autism Spectrum Disorder
- •Do not take any other probiotics for at least 3 weeks before and during the study period
排除标准
- •Autistic children with other neurodevelopmental disorders or psychiatric diseases
- •With a clinically significant chronic medical condition, including; anemia, brain malformations, metabolic diseases, epilepsy, organic gastrointestinal disorders (i.e. gastroesophageal reflux, food allergies, irritable bowel syndrome (IBS)) and Celiac disease
- •On anti-fungal, antibiotics, special diet (i.e. gluten-free diet, casein-free diet, high-protein diet, ketogenic diet) and current use of psychiatric medications within the preceding 3 weeks were excluded
- •Known allergy to probiotics
研究组 & 干预措施
Lactobacillus plantarum PS128 (PS128)
Subjects will receive oral Lactobacillus plantarum PS128 capsules, 2 capsules per day, for 16 weeks.
干预措施: Probiotic, Lactobacillus plantarum PS128 (Other)
Placebo
Subjects will receive oral placebo capsules, 2 capsules per day, for the first 8 weeks. The following 8 weeks, subjects will receive oral Lactobacillus plantarum PS128 capsules, 2 capsules per day, for 8 weeks.
干预措施: Placebo, microcrystalline cellulose (Other)
Normal Control
Normal control group are enrolled by invitation from the age and gender matched healthy children.
结局指标
主要结局
Changes from baseline of anxiety subscale in Children's Behavior Checklist (CBCL)/Achenbach System of Empirically Based Assessment (ASEBA) at week 8 and week 16
时间窗: Baseline, week 8 and week 16
ASEBA for behavioral assessment
Changes from hyperactivity subscale of Attention-Deficit/Hyperactivity Disorder Test (ADHDT) at week 8 and week 16
时间窗: Baseline, week 8 and week 16
Inattention, hyperactive symptoms evaluation
次要结局
- Change of total scores at week 8 and week 16 from baseline of Penn Interactive Peer Play Scale, (PIPPS)(Baseline, week 8 and week 16)
- Change of total scores at week 8 and week 16 from baseline of Social Interaction Assessment Scale(Baseline, week 8 and week 16)
- Gastrointestinal symptoms recorded by using GI Severity Index (6-GSI) at week 8 and week 16(Baseline, week 8 and week 16)
- Change of total scores at week 8 and week 16 from baseline of Changes of Childhood Asperger Syndrome Test (CAST)(Baseline, week 8 and week 16)
- Comparison of Microbiota composition between week 8 and baseline(Baseline and week 8)
研究者
Hui-Ju Chen
Senior Attending Physician
Mackay Memorial Hospital