Assessing the Impact of Probiotic Supplementation in Children Diagnosed with Autism Spectrum Disorder: the PROBI-O-TISM Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Mean change in ATEC (Autism Treatment Evaluation Checklist) total score between baseline and week 14
研究概览
简要总结
Children with autism spectrum disorder (ASD) present with stereotyped behaviors and often with comorbidities including gastrointestinal symptoms and sleep disturbances. These affect the quality of life of both children and parents. As of now, interventions available to manage ASD-related behaviors rely heavily on the services of professionals who are often difficult to access. What is even more striking is that there are currently no approved medications to treat the core symptoms of ASD. There is an important need for additional strategies to manage severity of ASD and to develop new treatments.
Targeting the bacteria living in the intestine, named 'gut microbiota', by using probiotics is an avenue that has been proposed by other groups to improve behaviors associated with ASD and gastrointestinal symptoms. However, these studies have important limitations, pressing the need for robustly designed interventions.
Previously, the PROBI-O-TISM pilot study was conducted at CHU Sainte-Justine. The investigators confirmed that the Bio-K+ probiotic beverage is acceptable and safe for autistic children and that the proposed study protocol is feasible. The study also led to promising preliminary results suggesting a beneficial effect of the probiotics on behaviors, gastrointestinal symptoms and sleep.
The proposed study will answer the question: ''Does supplementing with Bio-K+ probiotics reduce the severity of autistic behaviors and comorbidities in children with a diagnosis of ASD? '' The investigators will use a solid study design, a double-blinded randomized controlled-trial with placebo, to test the efficacy of a 14-week treatment with daily Bio-K+ probiotic supplement in children aged 4 to 11 years old. The investigators will also study the impact of the supplementation on other parameters such as quality of life, gut microbiota and brain signaling.
This is a unique opportunity to test a simple approach to improve behaviors and comorbidities in autistic children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being an autistic child with normal intelligence as documented by a neuropsychology assessment at the time of ASD diagnosis based on the ADOS score and the clinical impression of a multidisciplinary team of experts in autism diagnosis in the Department of Psychiatry;
- •Being between the ages of 4 and 11 years;
- •Acceptance and ability of the child to consume the probiotics product.
排除标准
- •Epilepsy;
- •Autism in the context of a genetic syndrome such as Fragile X or Bourneville sclerosis;
- •Known presence of cancer, diabetes, celiac disease or inflammatory bowel disease (Crohn's disease or ulcerative colitis);
- •Genetic disorder such as trisomy 21 or 14;
- •Immune system disorder;
- •Intolerance or allergy to Bio-K+ pea-based probiotics;
- •Having taken antibiotics or probiotics in the previous 3 months
研究组 & 干预措施
Probiotic
A fermented probiotic beverage containing 3 lactobacilli
干预措施: Three strains of Lactobacillus: L. acidophilus CL1285®, L. casei LBC80R® and L. rhamnosus CLR2® (Dietary Supplement)
Placebo
A beverage without bacteria (identical taste and nutritional content to the probiotic beverage)
干预措施: Placebo (Other)
结局指标
主要结局
Mean change in ATEC (Autism Treatment Evaluation Checklist) total score between baseline and week 14
时间窗: 14 weeks
Mean change in ATEC total score between baseline and week 14 will be compared to verify the supplementation effects. ATEC scale consists of 77 items grouped into four subscales: (1) language, (2) perception, (3) sociability and (4) behavior. The total score is 0-179; the higher the score, the more severe ASD-related behaviors
次要结局
- Mean change in each ATEC (Autism Treatment Evaluation Checklist) sub-scores (language, perception, sociability, and behavior) between baseline , week 14 and week 18 .(Baseline, 14 weeks and 18 weeks)
- Mean change in ATEC (Autism Treatment Evaluation Checklist) total score between week 14 and week 18(4 weeks)
- Mean change in Pediatric Quality of Life Inventory (PedsQL) score between baseline, week 14 and week 18.(Baseline, 14 weeks and 18 weeks)
- Mean change in Parenting Stress Index-Short Form (PSI-SF) score between baseline, week 14 and week 18.(Baseline, 14 weeks and 18 weeks)
- Mean change in ATEC (Autism Treatment Evaluation Checklist) total score at week 4 and week 8 from baseline.(4 weeks and 8 weeks)
- Mean change in VABS-III (adaptive behavior skills) total and sub-scores between baseline, week 14 and week 18.(Baseline, 14 weeks and 18 weeks)
- Mean change in 6-GSI (6-Gastrointestinal Severity Index) score between baseline, week 4, week 8, week 14 and week 18.(From baseline up to 18 weeks.)
- Mean change in CSHQ (Child's Sleep Habits Questionnaire) total and sub-scores between baseline, week 4, week 8, week 14 and week 18.(From baseline up to 18 weeks)
研究者
Valérie Marcil
Professor
St. Justine's Hospital