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NCT Number: NCT06906068

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

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.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Nervous System Diseases Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders

Age range

4 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Placebo

Other

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

Primary outcomes

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

    Time frame: 14 weeks

    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

Secondary outcomes

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

    Time frame: 4 weeks

    Mean change in ATEC total score between week 14 and week 18 will be compared to verify persistence of treatment effects after wash-out (product cessation). The total score is 0-179; the higher the score, the more severe ASD-related behaviors.

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

    Time frame: Baseline, 14 weeks and 18 weeks

    Mean change in each ATEC sub-scores (language, perception, sociability, and behavior) will be compared between baseline, week 14 to verify supplementation effect and week 18 to evaluate persistence of treatment effects after wash-out (product cessation). The total score is 0-179; the higher the score, the more severe ASD-related behaviors.

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

    Time frame: 4 weeks and 8 weeks

    Mean change in ATEC total score at week 4 and from baseline will be collected to document effect over time. The total score is 0-179; the higher the score, the more severe ASD-related behaviors

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

    Time frame: Baseline, 14 weeks and 18 weeks

    Mean change in VABS-III total and sub-scores will be compared between baseline, week 14 to determine supplementation effect and week 18 to verify persistence of treatment effects after wash-out (product cessation). It consists of four subscales: communication, daily living skills, socialization and motor skills. The total score (range 0-72) and the four sub-scores total will be calculated. The higher scores indicate higher levels of functioning.

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

    Time frame: From baseline up to 18 weeks.

    Mean change in 6-GSI score will be compared between baseline, week 4, week 8, week 14 to evaluate supplémentation effect and week 18 to verify to persistence of treatment effects after wash-out (product cessation).The total score is 0-12, with higher values indicating greater severity.

  6. Mean change in CSHQ (Child's Sleep Habits Questionnaire) total and sub-scores between baseline, week 4, week 8, week 14 and week 18.

    Time frame: From baseline up to 18 weeks

    Mean change in CSHQ total and sub-scores will be compared between baseline, week 4, week 8, week 14 to evaluate suplementation effects and week 18 to verify persistence of treatment effects after wash-out (product cessation). Total score is 33-99 divided in eight subscales: (1) bedtime resistance, (2) sleep-onset delay, (3) sleep duration, (4) sleep anxiety, (5) nocturnal awakenings, (6) parasomnias, (7) sleep disordered breathing and (8) morning waking/daytime sleepiness. The higher the CSHQ score the greater the complaints.

  7. Mean change in Pediatric Quality of Life Inventory (PedsQL) score between baseline, week 14 and week 18.

    Time frame: Baseline, 14 weeks and 18 weeks

    Mean change in PedsQL score will be compared between baseline, week 14 to evaluate supplementation effects and week 18 to verify persistence of treatment effects after wash-out (product cessation). PedsQ consists in 23 items and four subscales: physical functioning, emotional functioning, social functioning and school functioning. A higher score represents better health related QoL.

  8. Mean change in Parenting Stress Index-Short Form (PSI-SF) score between baseline, week 14 and week 18.

    Time frame: Baseline, 14 weeks and 18 weeks

    Mean change in PSI-SF score will be compared between baseline, week 14 to determine supplementation effects and week 18 to verify persistence of treatment effects after wash-out (product cessation). It is divided into three domains: parental distress, dysfunctional parent-child interaction and difficult child, with a total score ranging from 36 to 180. A higher score indicates a higher clinical level of distress.

Study contacts

Contact information is provided by the study sponsor or research team.

Ghizlane Gaougaou, Research associate

CONTACT

[email protected]

514 345-4931 ext. 5745

Valérie Marcil, Professor

CONTACT

[email protected]

514 345-4931 ext. 3272

Sponsors and collaborators

Lead sponsor

Valérie Marcil

Other

Collaborators

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

Registry information

Acronym: (PROBI-O-TISM)

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 2, 2025
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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