An interventional study of Probiotics and Placebo in Autism Spectrum Disorder, sponsored by BioGaia AB. Not yet recruiting at 1 site in Argentina. Open to participants aged 4 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by BioGaia AB · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Probiotic oil drops formulation. Administered once daily.
Dietary Supplement: Probiotics
Placebo oil drops formulation. Administered once daily.
Dietary Supplement: Placebo
Combination of L. reuteri strains.
Placebo identical to the active product, except the addition of probiotics.
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.
Time frame: From baseline to end of study (6 months)
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.
Time frame: 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.
Time frame: 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 higher scores indicating more severe symptoms.
Time frame: 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, domain scores and general adaptive composite.
Time frame: 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.
Time frame: At 6 months
Change in Family Quality of Life
Change in family Quality of Life (QoL), assessed by the PedsQL Family Impact Module, in the L. reuteri group compared to the placebo group. A higher score indicates a better quality of life.
Time frame: From baseline to end fo study (6 months)
Change in quality of sleep
Change in sleep quality, assessed by the Children's Sleep Habits Questionnaire, in the L. reuteri group compared to placebo. The CSHQ is scored on 33 of 52 items, using a 1-3 scale, with a total score of 41 or higher indicating potential sleep problems.
Time frame: From baseline to end of study (6 months)
Impact of dietary habits
Impact of dietary habits, assessed by a Food Frequency Questionnaire (FFQ), on the gut microbiota profile and effect of the L. reuteri intervention.
Time frame: At baseline and end of study (6 months)
Changes in gut microbiota structure and composition
Changes in the gut microbiota structure and composition and the effect of the L. reuteri intervention, assessed by metagenomic analysis of fecal samples
Time frame: Baseline, 3 and 6 months
Plan to share: Undecided
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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