Probiotics for Autism

((PROBI-O-TISM) Trial)

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

108 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Bio-K+ Probiotics for autism?

Research suggests that probiotics may help improve some autism symptoms by affecting the gut-brain connection. In one study, children with autism who took probiotics showed improvements in social and sensory behaviors, especially those without gastrointestinal issues. Another study in mice found that certain probiotics improved social behaviors and gut health. ^{1 2 3 4 5}

Is it safe to use probiotics for autism treatment?

Probiotics, including Lactobacillus plantarum and VISBIOME, have been studied in children with autism and generally show few side effects, with some studies reporting fewer side effects than placebo. These findings suggest that probiotics are generally safe for use in humans, including children with autism. ^{1 6 7 8 9}

How does the Bio-K+ Probiotics treatment differ from other autism treatments?

Bio-K+ Probiotics is unique because it focuses on improving gut health by balancing intestinal bacteria, which may help alleviate autism symptoms, especially gastrointestinal issues. Unlike traditional autism treatments that target behavioral symptoms directly, this probiotic approach aims to enhance gut-brain communication, potentially influencing neurotransmitter levels and reducing neuroinflammation. ^{2 6 10 11 12}

What is the purpose of this trial?

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.

Research Team

Valérie Marcil, Professor

Principal Investigator

St. Justine's Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Probiotic Supplementation on Gastrointestinal, Sensory and Core Symptoms in Autism Spectrum Disorders: A Randomized Controlled Trial. [2022]

2. Saudi Arabia pubmed.ncbi.nlm.nih.gov

The role of nutraceuticals in the management of autism. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Nutritional Intervention as a Complementary Neuroprotective Approach against Propionic Acid-Induced Neurotoxicity and Associated Biochemical Autistic Features in Rat Pups. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Selective Probiotic Treatment Positively Modulates the Microbiota-Gut-Brain Axis in the BTBR Mouse Model of Autism. [2022]

5. China 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. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Characterization of Intestinal Microbiota and Probiotics Treatment in Children With Autism Spectrum Disorders in China. [2020]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Lactobacillus plantarum PS128 and Other Probiotics in Children and Adolescents with Autism Spectrum Disorder: A Real-World Experience. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Lactobacillus plantarum ST-III modulates abnormal behavior and gut microbiota in a mouse model of autism spectrum disorder. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Probiotics for Gastrointestinal Symptoms and Quality of Life in Autism: A Placebo-Controlled Pilot Trial. [2020]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Bifidobacterium longum CCFM1077 Ameliorated Neurotransmitter Disorder and Neuroinflammation Closely Linked to Regulation in the Kynurenine Pathway of Autistic-like Rats. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Probiotic Ameliorating Effects of Altered GABA/Glutamate Signaling in a Rodent Model of Autism. [2023]

12. France pubmed.ncbi.nlm.nih.gov

Ameliorative effect of probiotics (Lactobacillus paracaseii and Protexin®) and prebiotics (propolis and bee pollen) on clindamycin and propionic acid-induced oxidative stress and altered gut microbiota in a rodent model of autism. [2019]