Clinical trial NCT06906068: Assessing the Impact of Probiotic Supplementation in Children Diagnosed With Autism Spectrum Disorder: the PROBI-O-TISM Study
Official title: Assessing the Impact of Probiotic Supplementation in Children Diagnosed With Autism Spectrum Disorder: the PROBI-O-TISM Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Gastrointestinal symptoms
Sleep disorder
Probiotics
Microbiota
Autism Spectrum Disorder
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
Collaborators: name: Hôpital du Sacré-Coeur de Montréal (CIUSSS - NIM)
name: University of Ottawa
name: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
name: Institut National de la Recherche Scientifique - Centre Armand Frappier Santé Biotechnologie
First posted: 2025-04-02
Enrollment: 108
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mean change in ATEC (Autism Treatment Evaluation Checklist) total score between baseline and week 14
timeFrame: 14 weeks
Secondary outcomes:
measure: Mean change in ATEC (Autism Treatment Evaluation Checklist) total score between week 14 and week 18
timeFrame: 4 weeks
measure: Mean change in each ATEC (Autism Treatment Evaluation Checklist) sub-scores (language, perception, sociability, and behavior) between baseline , week 14 and week 18 .
timeFrame: Baseline, 14 weeks and 18 weeks
measure: Mean change in ATEC (Autism Treatment Evaluation Checklist) total score at week 4 and week 8 from baseline.
timeFrame: 4 weeks and 8 weeks
measure: Mean change in VABS-III (adaptive behavior skills) total and sub-scores between baseline, week 14 and week 18.
timeFrame: Baseline, 14 weeks and 18 weeks
measure: Mean change in 6-GSI (6-Gastrointestinal Severity Index) score between baseline, week 4, week 8, week 14 and week 18.
timeFrame: From baseline up to 18 weeks.
measure: Mean change in CSHQ (Child's Sleep Habits Questionnaire) total and sub-scores between baseline, week 4, week 8, week 14 and week 18.
timeFrame: From baseline up to 18 weeks
measure: Mean change in Pediatric Quality of Life Inventory (PedsQL) score between baseline, week 14 and week 18.
timeFrame: Baseline, 14 weeks and 18 weeks
measure: Mean change in Parenting Stress Index-Short Form (PSI-SF) score between baseline, week 14 and week 18.
timeFrame: Baseline, 14 weeks and 18 weeks
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
Study officials:
affiliation: St. Justine's Hospital
name: Valérie Marcil, Professor
role: PRINCIPAL_INVESTIGATOR
References: