Autism Spectrum DisorderNCT07845253
Effect of Limosilactobacillus Reuteri on Social Deficits in Children With Autistic Spectrum Disorder
A study testing Probiotics in people with Autism Spectrum Disorder, run by BioGaia AB at 1 site in Argentina.
Trial summary
This is a double-blind, randomized, placebo-controlled, parallel-group study in children with Autism Spectrum Disorder (ASD) to evaluate the effect of a probiotic product on the ASD symptoms. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteArgentina
- Study dates
- 15 Oct 2026to 31 Oct 2027
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Boys or girls aged between 4 to 12 years at screening.
- ASD diagnosis confirmed by a qualified clinician according to DMS-5 criteria, M-CHAT used as a screening tool.
- Parents/caregivers/legal guardians are ≥18 years.
- Readiness and the opportunity for parents/caregivers/legal guardians to fill out a study diary, questionnaires, and report regularly during the intervention period.
- Parents/caregivers/legal guardians with ability to understand and comply with the requirements of the study, as judged by the Investigator.
- Parents/caregivers/legal guardians willing and able to give informed consent for their and their child's participation in the study.
Who cannot join
- Neurological syndromes that could explain autism disorders.
- Organic gastrointestinal disorders (e.g. IBD, peptic ulcers and cancer). Celiac disease is accepted
- Any other severe clinically relevant disease or disorder which may affect the participation in the study, based on the investigator's judgement.
- Allergy or intolerance to one of the excipients of the probiotic product.
- Children with reported exposure to probiotic supplements in the 15 days prior to Screening Visit (V1).
- Children with reported exposure to oral and/or systemic antibiotics in the 7 days prior to Screening Visit (V1).
- Children with reported exposure to proton pump inhibitors in the 7 days prior to Screening Visit (V1).
- Participation in other interventional clinical study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Argentina1 site
Sanatorio Maipú
Mendoza, Maipú, M5515DUF
Romina L Squartini, MD, +54 261 7539084, lrsquartini@gmail.com
Eugenia Yañez, +54 261 6594152, eyanezic@gmail.com
About this study
Official title: Effect of Limosilactobacillus Reuteri on Social Deficits in Children With Autistic Spectrum Disorder: a Double-blind, Randomized, Placebo-controlled, Parallel-group Clinical Study
This is a double-blind, randomized, placebo-controlled, parallel-group study in children with Autism Spectrum Disorder (ASD) to evaluate the effect of a probiotic product on the ASD symptoms.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Probiotics, Placebo
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
Combination of L. reuteri strains.
PlaceboDietary supplement
Placebo identical to the active product, except the addition of probiotics.
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Experimental | Probiotic oil drops formulation. Administered once daily. Receives: Dietary Supplement: Probiotics |
| Placebo | Placebo comparator | Placebo oil drops formulation. Administered once daily. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Social Responsiveness Scale-2 (SRS-2) score
Changes in the SRS-2 score in the L. reuteri group compared to the placebo group. The SRS-2 is a 65-item questionnaire, with higher scores indicating greater social impairment and severity of autism-related traits.
Measured: From baseline to end of study (6 months)
Secondary outcomes (5)
Change in Autism Diagnostic Observation Schedule, 2nd Ed (ADOS-2) Calibrated Severity Score (CSS) for Social Affect
Change in ADOS-2 CSS for Social Affect in the L. reuteri group compared to the placebo group.
ADOS-2 is a semi-structured, standardized assessment that observes social interaction, communication, play, and restricted or repetitive behaviors across five modules tailored to age and language level. Higher scores indicate a higher level of autism-related behaviors.
Measured: From baseline to end of study (6 months)
Change in total Autism Diagnostic Observation Schedule, 2nd Ed (ADOS-2) score
Change in total ADOS-2 score in the L. reuteri group compared to the placebo group.
ADOS-2 is a semi-structured, standardized assessment that observes social interaction, communication, play, and restricted or repetitive behaviors across five modules tailored to age and language level. Higher scores indicate a higher level of autism-related behaviors.
Measured: From baseline to end of study (6 months)
Change in GI symptoms
Change in GI symptoms, assessed by the 6 item Gastrointestinal Severity Index (6-GSI) in the L. reuteri group compared to the placebo group.
6-GSI is a six item questionnaire with total score 0-12 with higher scores indicating worse outcome.
Measured: From baseline to end fo study (6 months)
Change in ABAS-2 score
Change in adaptive behaviour, assessed by the Adaptive Behavior Assessment System, Second Edition (ABAS-2) in the L. reuteri group compared to the placebo group.
ABAS-2 is a 4-point rating scale with the scoring system divided into skill area scores (range 1 to 19), domain scores (range 40 to 160) and general adaptive composite (40 to 150). A higher score indicates a better outcome.
Measured: From baseline to end fo study (6 months)
Proportion of responders
Proportion of responders at 6 months, evaluating all assessments and questionnaires, in the L. reuteri group compared to the placebo group.
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start15 Oct 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioGaia AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Romina L Squartini, MD, Principal investigator, Sanatorio Maipú
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845253
- Sponsor's protocol ID
- CSUB0223
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Limosilactobacillus Reuteri on Social Deficits in Children With Autistic Spectrum Disorder: a Double-blind, Randomized, Placebo-controlled, Parallel-group Clinical Study
- ClinicalTrials.gov ID
- NCT07845253
- Acronym / sponsor ID
- CSUB0223
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- BioGaia ABIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 28 Sep 2026 (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.
This is a double-blind, randomized, placebo-controlled, parallel-group study in children with Autism Spectrum Disorder (ASD) to evaluate the effect of a probiotic product on the ASD symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Experimental | Dietary Supplement: ProbioticsProbiotic oil drops formulation. Administered once daily. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo oil drops formulation. Administered once daily. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Boys or girls aged between 4 to 12 years at screening.
- ASD diagnosis confirmed by a qualified clinician according to DMS-5 criteria, M-CHAT used as a screening tool.
- Parents/caregivers/legal guardians are ≥18 years.
- Readiness and the opportunity for parents/caregivers/legal guardians to fill out a study diary, questionnaires, and report regularly during the intervention period.
- Parents/caregivers/legal guardians with ability to understand and comply with the requirements of the study, as judged by the Investigator.
Key exclusion criteria (8 listed)
- Neurological syndromes that could explain autism disorders.
- Organic gastrointestinal disorders (e.g. IBD, peptic ulcers and cancer). Celiac disease is accepted
- Any other severe clinically relevant disease or disorder which may affect the participation in the study, based on the investigator's judgement.
- Allergy or intolerance to one of the excipients of the probiotic product.
- Children with reported exposure to probiotic supplements in the 15 days prior to Screening Visit (V1).
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 |
|---|---|---|
| ProbioticsCombination of L. reuteri strains. | Dietary supplement | Probiotics |
| PlaceboPlacebo identical to the active product, except the addition of probiotics. | Dietary supplement | Placebo |
Primary outcome
Changes in Social Responsiveness Scale-2 (SRS-2) score
Time frame: From baseline to end of study (6 months)
Changes in the SRS-2 score in the L. reuteri group compared to the placebo group. The SRS-2 is a 65-item questionnaire, with higher scores indicating greater social impairment and severity of autism-related traits.
5 secondary outcomes
Change in Autism Diagnostic Observation Schedule, 2nd Ed (ADOS-2) Calibrated Severity Score (CSS) for Social Affect
Time frame: From baseline to end of study (6 months)
Change in total Autism Diagnostic Observation Schedule, 2nd Ed (ADOS-2) score
Time frame: From baseline to end of study (6 months)
Change in GI symptoms
Time frame: From baseline to end fo study (6 months)
Change in ABAS-2 score
Time frame: From baseline to end fo study (6 months)
Proportion of responders
Time frame: At 6 months
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 30 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Romina L Squartini, MD principal investigator
Sanatorio Maipú
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics in people with Autism Spectrum Disorder, run by BioGaia AB at 1 site in Argentina.
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 6 inclusion and 8 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 30 Sep 2026. 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 Argentina. 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 Sanna H Nystrom, PhD (+46761483866, sny@biogaia.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Social Responsiveness Scale-2 (SRS-2) score (time frame: From baseline to end of study (6 months)). 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 30 Sep 2026.