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

NCT ID: NCT06906068

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-02
• Study Completion Date: 2028-04-30

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.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Probiotic

A fermented probiotic beverage containing 3 lactobacilli

Group Type: EXPERIMENTAL

Three strains of Lactobacillus: L. acidophilus CL1285®, L. casei LBC80R® and L. rhamnosus CLR2®

Intervention Type: DIETARY_SUPPLEMENT

A probiotic beverage (98 g) at dose of 50.10\^9 CFU, taken once daily for 14 weeks.

Placebo

A beverage without bacteria (identical taste and nutritional content to the probiotic beverage)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Non fermented beverage (98 g) with no probiotic strains, taken once daily for 14 weeks.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Non fermented beverage (98 g) with no probiotic strains, taken once daily for 14 weeks.

Intervention Type: OTHER

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hôpital du Sacré-Coeur de Montréal (CIUSSS - NIM)

UNKNOWN

Sponsor Role: collaborator

University of Ottawa

OTHER

Sponsor Role: collaborator

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

OTHER

Sponsor Role: collaborator

Institut National de la Recherche Scientifique - Centre Armand Frappier Santé Biotechnologie

UNKNOWN

Sponsor Role: collaborator

Valérie Marcil

OTHER

Sponsor Role: lead

Responsible Party

Valérie Marcil

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Valérie Marcil, Professor

Role: PRINCIPAL_INVESTIGATOR

St. Justine's Hospital

Locations

CHU Sainte-Justine

Montreal, Quebec, Canada

Countries

Canada

Central Contacts

Valérie Marcil, Professor

Role: CONTACT

valerie.marcil@umontreal.ca

514 345-4931 ext. 3272

Ghizlane Gaougaou, Research associate

Role: CONTACT

ghizlane.gaougaou@umontreal.ca

514 345-4931 ext. 5745

Facility Contacts

Valérie Marcil, Professor

Role: primary

valerie.marcil@umontreal.ca

514-345-4931 ext. 3272

Ghizlane Gaougaou, Research Associate

Role: backup

ghizlane.gaougaou@umontreal.ca

514-345-4931 ext. 5745

Other Identifiers

2025-8319

Identifier Type: -

Identifier Source: org_study_id