Autism Spectrum Disorder(PROBI-O-TISM)NCT06906068
Assessing the Impact of Probiotic Supplementation in Children Diagnosed With Autism Spectrum Disorder: the PROBI-O-TISM Study
A study testing Three strains of Lactobacillus: L. acidophilus CL1285®, L. casei LBC80R® and L. rhamnosus CLR2® in people with Autism Spectrum Disorder, run by Valérie Marcil at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 11 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Three strains of Lactobacillus: L. acidophilus CL1285®, L. casei LBC80R® and L. rhamnosus CLR2®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteCanada
- Study dates
- 2 Jun 2025to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
CHU Sainte-Justine
Montreal, Quebec, H3T 1C5
Valérie Marcil, Professor, 514-345-4931 ext. 3272, valerie.marcil@umontreal.ca
Ghizlane Gaougaou, Research Associate, 514-345-4931 ext. 5745, ghizlane.gaougaou@umontreal.ca
About this 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.
Read more
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
- Being tested
- Three strains of Lactobacillus: L. acidophilus CL1285®, L. casei LBC80R® and L. rhamnosus CLR2®, Placebo
- Keywords
- Gastrointestinal symptoms, Sleep disorder, Probiotics, Microbiota, Autism Spectrum Disorder
- Medical subject headings
- Autism Spectrum Disorder, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboOther
Non fermented beverage (98 g) with no probiotic strains, taken once daily for 14 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | A fermented probiotic beverage containing 3 lactobacilli Receives: 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) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 weeks
Secondary outcomes (8)
Mean change in ATEC (Autism Treatment Evaluation Checklist) total score between week 14 and week 18
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.
Measured: 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 .
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.
Measured: Baseline, 14 weeks and 18 weeks
Mean change in ATEC (Autism Treatment Evaluation Checklist) total score at week 4 and week 8 from baseline.
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
Measured: 4 weeks and 8 weeks
Mean change in VABS-III (adaptive behavior skills) total and sub-scores between baseline, week 14 and week 18.
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.
Measured: 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.
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.
Measured: From baseline up to 18 weeks.
Mean change in CSHQ (Child's Sleep Habits Questionnaire) total and sub-scores between baseline, week 4, week 8, week 14 and week 18.
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.
Measured: From baseline up to 18 weeks
Mean change in Pediatric Quality of Life Inventory (PedsQL) score between baseline, week 14 and week 18.
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.
Measured: Baseline, 14 weeks and 18 weeks
Mean change in Parenting Stress Index-Short Form (PSI-SF) score between baseline, week 14 and week 18.
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.
Measured: Baseline, 14 weeks and 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start2 Jun 2025 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Valérie Marcil
- Sponsor type
- University, hospital or other
- Collaborators
- Hôpital du Sacré-Coeur de Montréal (CIUSSS - NIM), University of Ottawa, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval, Institut National de la Recherche Scientifique - Centre Armand Frappier Santé Biotechnologie
- Responsible party
- Sponsor-investigator, Valérie Marcil, St. Justine's Hospital
- Investigators
- Valérie Marcil, Professor, Principal investigator, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906068
- Sponsor's protocol ID
- 2025-8319
- Acronym
- (PROBI-O-TISM)
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD might be shared to other research upon resonable request to the Principal Investigator/Sponsor.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Probiotic Supplementation in Children Diagnosed With Autism Spectrum Disorder: the PROBI-O-TISM Study
- ClinicalTrials.gov ID
- NCT06906068
- Acronym / sponsor ID
- (PROBI-O-TISM) / 2025-8319
- Conditions
- Autism Spectrum Disorder
- Keywords
- Gastrointestinal symptoms, Sleep disorder, Probiotics, Microbiota, Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Valérie MarcilUniversity, hospital or other
- Collaborators
- Hôpital du Sacré-Coeur de Montréal (CIUSSS - NIM), University of Ottawa, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval, Institut National de la Recherche Scientifique - Centre Armand Frappier Santé Biotechnologie
- Study start
- 2 Jun 2025 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: Three strains of Lactobacillus: L. acidophilus CL1285®, L. casei LBC80R® and L. rhamnosus CLR2®A fermented probiotic beverage containing 3 lactobacilli |
| Placebo | Placebo comparator | Other: PlaceboA beverage without bacteria (identical taste and nutritional content to the probiotic beverage) |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Three strains of Lactobacillus: L. acidophilus CL1285®, L. casei LBC80R® and L. rhamnosus CLR2®A probiotic beverage (98 g) at dose of 50.10^9 CFU, taken once daily for 14 weeks. | Dietary supplement | Probiotic |
| PlaceboNon fermented beverage (98 g) with no probiotic strains, taken once daily for 14 weeks. | Other | Placebo |
Primary outcome
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
8 secondary outcomes
Mean change in ATEC (Autism Treatment Evaluation Checklist) total score between week 14 and week 18
Time frame: 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 .
Time frame: Baseline, 14 weeks and 18 weeks
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 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 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 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 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 Parenting Stress Index-Short Form (PSI-SF) score between baseline, week 14 and week 18.
Time frame: Baseline, 14 weeks and 18 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: Undecided. IPD might be shared to other research upon resonable request to the Principal Investigator/Sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Valérie Marcil, Professor principal investigator
St. Justine's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Three strains of Lactobacillus: L. acidophilus CL1285®, L. casei LBC80R® and L. rhamnosus CLR2® in people with Autism Spectrum Disorder, run by Valérie Marcil at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valérie Marcil, Professor (514 345-4931 ext. 3272, valerie.marcil@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in ATEC (Autism Treatment Evaluation Checklist) total score between baseline and week 14 (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.