Assessing the Impact of Probiotic Supplementation in Children Diagnosed With Autism Spectrum Disorder: the PROBI-O-TISM Study

Обзор

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.

Вмешательства

• Пищевая добавка Three strains of Lactobacillus: L. acidophilus CL1285®, L. casei LBC80R® and L. rhamnosus CLR2®
  A probiotic beverage (98 g) at dose of 50.10\^9 CFU, taken once daily for 14 weeks.
• Другое Placebo
  Non fermented beverage (98 g) with no probiotic strains, taken once daily for 14 weeks.

Первичные конечные точки

• Mean change in ATEC (Autism Treatment Evaluation Checklist) total score between baseline and week 14 [Срок оценки: 14 weeks]

Вторичные конечные точки (8)

• Mean change in ATEC (Autism Treatment Evaluation Checklist) total score between week 14 and week 18 [Срок оценки: 4 weeks]
• Mean change in each ATEC (Autism Treatment Evaluation Checklist) sub-scores (language, perception, sociability, and behavior) between baseline , week 14 and week 18 . [Срок оценки: Baseline, 14 weeks and 18 weeks]
• Mean change in ATEC (Autism Treatment Evaluation Checklist) total score at week 4 and week 8 from baseline. [Срок оценки: 4 weeks and 8 weeks]
• Mean change in VABS-III (adaptive behavior skills) total and sub-scores between baseline, week 14 and week 18. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: From baseline up to 18 weeks]
• Mean change in Pediatric Quality of Life Inventory (PedsQL) score between baseline, week 14 and week 18. [Срок оценки: Baseline, 14 weeks and 18 weeks]
• Mean change in Parenting Stress Index-Short Form (PSI-SF) score between baseline, week 14 and week 18. [Срок оценки: Baseline, 14 weeks and 18 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Канада · 1 центр

• CHU Sainte-Justine — Montreal

Идентификаторы

NCT: NCT06906068 · 2025-8319

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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