Probiotics for Autism

((PROBI-O-TISM) Trial)

Not yet recruiting at 1 trial location

Overseen By Ghizlane Gaougaou, Research associate

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Valérie Marcil

Must not be taking: Antibiotics, Probiotics

Disqualifiers: Epilepsy, Cancer, Diabetes, others

Compensation: Varies

Number of Visits: Unknown

Duration: 14 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a daily Bio-K+ probiotic supplement can reduce the severity of behaviors and related issues in children with autism spectrum disorder (ASD). The study assesses the effects of probiotics on behaviors, gut health, and sleep quality using a controlled method. Some children receive the probiotic, while others receive a look-alike drink without active ingredients. This simple and promising approach may improve the lives of children with ASD and their families. Suitable candidates for this trial have an autism diagnosis, normal intelligence, and can consume the probiotic drink. As an unphased trial, this study offers participants a unique opportunity to contribute to groundbreaking research that could enhance the quality of life for children with ASD.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have taken antibiotics or probiotics in the last 3 months.

What prior data suggests that Bio-K+ probiotics are safe for children with autism?

In a previous study, researchers found that the Bio-K+ probiotic drink is safe and suitable for autistic children aged 4 to 11. The study showed that children tolerated the probiotics well, with no serious side effects. This finding suggests that adding Bio-K+ probiotics to the daily routine of children with autism might be a low-risk option to consider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for autism, which often include behavioral therapies and medications targeting symptoms like irritability, Bio-K+ Probiotics introduces a novel approach by using live bacteria to potentially influence gut health and, in turn, impact behavior. Researchers are excited about this treatment because it leverages the gut-brain axis, a pathway that is gaining attention for its role in neurological conditions. This probiotic beverage contains three specific lactobacilli, which are believed to promote a healthier gut microbiome. By focusing on the gut's influence on the brain, this treatment could offer a more natural and holistic option for managing autism symptoms.

What evidence suggests that Bio-K+ probiotics might be an effective treatment for autism?

Research has shown that Bio-K+ probiotics, which participants in this trial may receive, might help with behaviors and symptoms related to autism spectrum disorder (ASD). Early results from a small study found that these probiotics improved behavior, digestive issues, and sleep in children with autism. The study also confirmed that the Bio-K+ probiotic drink is safe and easy for children with ASD to take. While more research is needed, these early findings suggest that Bio-K+ probiotics could be a helpful option for managing some autism symptoms. ^{1 2 3 4 6}

Who Is on the Research Team?

Valérie Marcil, Professor

Principal Investigator

St. Justine's Hospital

Are You a Good Fit for This Trial?

This trial is for children aged 4 to 11 with Autism Spectrum Disorder (ASD). They should have stereotyped behaviors and may also experience gastrointestinal issues or sleep disturbances. Children who've previously tolerated the Bio-K+ probiotic beverage are eligible.

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

Acceptance and ability of the child to consume the probiotics product

I am between 4 and 11 years old.

Exclusion Criteria

Intolerance or allergy to Bio-K+ pea-based probiotics

I have autism linked to a genetic condition like Fragile X.

I have epilepsy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a daily Bio-K+ probiotic supplement for 14 weeks

14 weeks

Follow-up

Participants are monitored for persistence of treatment effects after wash-out

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bio-K+ Probiotics

Trial Overview The study tests if a daily Bio-K+ probiotic supplement can reduce ASD-related behaviors and improve comorbidities like gut symptoms and sleep over 14 weeks. It's a double-blinded, randomized controlled-trial comparing the effects of the supplement against a placebo.

How Is the Trial Designed?

Group I: Probiotic Experimental Treatment 1 Intervention

A fermented probiotic beverage containing 3 lactobacilli

Group II: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Valérie Marcil

Lead Sponsor

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

Collaborator

University of Ottawa

Collaborator

Trials

231

Recruited

267,000+

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

Collaborator

Trials

26

Recruited

6,300+

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

Collaborator

Trials

1

Recruited

420+

Published Research Related to This Trial

In a double-blind, placebo-controlled trial involving 85 preschoolers with Autism Spectrum Disorder (ASD), probiotics did not show significant effects on the overall autism severity scores for the entire group, indicating limited efficacy in the general population studied.

However, in children without gastrointestinal symptoms, those treated with probiotics showed a significant reduction in autism severity scores, suggesting that probiotics may benefit specific subgroups of children with ASD, particularly those without GI issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Probiotic Supplementation on Gastrointestinal, Sensory and Core Symptoms in Autism Spectrum Disorders: A Randomized Controlled Trial. Santocchi, E., Guiducci, L., Prosperi, M., et al.[2022]

In a study involving 131 autistic children and adolescents, the use of the probiotic Lactobacillus plantarum PS128 led to significant improvements in symptoms of Autism Spectrum Disorder with very few side effects.

Younger children showed more pronounced benefits from Lactobacillus plantarum PS128 compared to other probiotics, supporting its specific efficacy in managing symptoms of autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lactobacillus plantarum PS128 and Other Probiotics in Children and Adolescents with Autism Spectrum Disorder: A Real-World Experience. Mensi, MM., Rogantini, C., Marchesi, M., et al.[2021]

The pilot trial involving 13 children with autism spectrum disorder (ASD) showed that the probiotic VISBIOME was safe and led to improvements in gastrointestinal symptoms, with no serious adverse events reported.

While the overall quality of life scores (PedsQL) did not reach statistical significance, there was a notable improvement in GI complaints with the probiotic compared to placebo, suggesting potential benefits that merit further investigation in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probiotics for Gastrointestinal Symptoms and Quality of Life in Autism: A Placebo-Controlled Pilot Trial. Arnold, LE., Luna, RA., Williams, K., et al.[2020]

In a study of 41 children with autism spectrum disorder (ASD), combining probiotics with applied behavior analysis (ABA) significantly improved behavioral symptoms compared to ABA alone, as measured by the Autism Treatment Evaluation Checklist (ATEC) after 3 months.

The addition of probiotics also led to beneficial changes in intestinal flora, increasing beneficial bacteria like Bifidobacterium and Lactobacillus while reducing harmful bacteria such as Shigella and Clostridium, suggesting a potential mechanism for the observed improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of probiotics combined with applied behavior analysis in the treatment of children with autism spectrum disorder: a prospective randomized controlled trial. Li, YQ., Sun, YH., Liang, YP., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40413384/

Acceptability and safety of a probiotic beverage ... This study aims to evaluate the acceptability and safety of a Bio-K + probiotics beverage in autistic children aged 4 to 11 years

2. jneurodevdisorders.biomedcentral.com jneurodevdisorders.biomedcentral.com/articles/10.1186/s11689-025-09617-5

Acceptability and safety of a probiotic beverage ... This study aims to evaluate the acceptability and safety of a Bio-K + probiotics beverage in autistic children aged 4 to 11 years

3. webapps.cihr-irsc.gc.ca webapps.cihr-irsc.gc.ca/decisions/p/project_details.html?applId=523583&lang=en

Detailed information - Funding Decisions Database - CIHR We 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 ...

4. researchgate.net researchgate.net/publication/389131837_Acceptability_and_safety_of_a_probiotic_beverage_supplementation_Bio-K_and_feasibility_of_the_proposed_protocol_in_children_with_a_diagnosis_of_autism_spectrum_disorder

(PDF) Acceptability and safety of a probiotic beverage ... Acceptability and safety of a probiotic beverage supplementation (Bio-K+) and feasibility of the proposed protocol in children with a diagnosis ...

5. withpower.com withpower.com/trial/phase-autistic-disorder-5-2025-d56b1

Probiotics for Autism · Info for Participants · Clinical Trial 2025 What data supports the effectiveness of the treatment Bio-K+ Probiotics for autism? Research suggests that probiotics may help improve some autism symptoms ...

6. link.springer.com link.springer.com/article/10.1007/s10802-024-01278-7

Effect of Probiotics on the Symptomatology of Autism ... Acceptability and safety of a probiotic beverage supplementation (Bio-K +) and feasibility of the proposed protocol in children with a ...