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

Valérie Marcil

Status: Begins enrollment in 1 month

Conditions: Autism Spectrum Disorder

Treatments: Dietary Supplement: Three strains of Lactobacillus: L. acidophilus CL1285®, L. casei LBC80R® and L. rhamnosus CLR2®; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06906068

2025-8319

Details and patient eligibility

About

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.

Enrollment: 108 estimated patients

Sex: All

Ages: 4 to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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108 participants in 2 patient groups, including a placebo group

Probiotic

Experimental group

Description:

A fermented probiotic beverage containing 3 lactobacilli

Treatment:

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

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo