Status:
NOT_YET_RECRUITING
Assessing the Impact of Probiotic Supplementation in Children Diagnosed With Autism Spectrum Disorder: the PROBI-O-TISM Study
Lead Sponsor:
Valérie Marcil
Collaborating Sponsors:
Hôpital du Sacré-Coeur de Montréal (CIUSSS - NIM)
University of Ottawa
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
4-11 years
Phase:
NA
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 lif...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2028
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT06906068
Start Date
June 2 2025
End Date
April 30 2028
Last Update
April 2 2025
Active Locations (1)
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1
CHU Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5