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

NCT06906068 | Not Yet Recruiting DMC

• 1 other identifier: 2025-8319
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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

Keywords

Gastrointestinal symptoms; Sleep disorder; Probiotics; Microbiota; Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• Mean change in ATEC (Autism Treatment Evaluation Checklist) total score between baseline and week 14

  Mean change in ATEC total score between baseline and week 14 will be compared to verify the supplementation effects. ATEC scale consists of 77 items grouped into four subscales: (1) language, (2) perception, (3) sociability and (4) behavior. The total score is 0-179; the higher the score, the more severe ASD-related behaviors

  14 weeks

Secondary Outcomes (8)

• Mean change in ATEC (Autism Treatment Evaluation Checklist) total score between week 14 and week 18

  4 weeks

• Mean change in each ATEC (Autism Treatment Evaluation Checklist) sub-scores (language, perception, sociability, and behavior) between baseline , week 14 and week 18 .

  Baseline, 14 weeks and 18 weeks

• Mean change in ATEC (Autism Treatment Evaluation Checklist) total score at week 4 and week 8 from baseline.

  4 weeks and 8 weeks

• Mean change in VABS-III (adaptive behavior skills) total and sub-scores between baseline, week 14 and week 18.

  Baseline, 14 weeks and 18 weeks

• Mean change in 6-GSI (6-Gastrointestinal Severity Index) score between baseline, week 4, week 8, week 14 and week 18.

  From baseline up to 18 weeks.

Study Arms (2)

Probiotic

EXPERIMENTAL

A fermented probiotic beverage containing 3 lactobacilli

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

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

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

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

Probiotic

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Valérie Marcil: lead
• Hôpital du Sacré-Coeur de Montréal (CIUSSS - NIM): collaborator
• University of Ottawa: collaborator
• Institut universitaire de cardiologie et de pneumologie de Québec, University Laval: collaborator
• Institut National de la Recherche Scientifique - Centre Armand Frappier Santé Biotechnologie: collaborator

Study Sites (1)

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Valérie Marcil, Professor

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valérie Marcil, Professor

CONTACT

514 345-4931; valerie.marcil@umontreal.ca

Ghizlane Gaougaou, Research associate

CONTACT

514 345-4931; ghizlane.gaougaou@umontreal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: April 2, 2025
• Study Start: June 2, 2025
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

CA (1)