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.
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.
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.
Parallel
Probiotics
Dietary supplementCombination of L. reuteri strains.
Placebo
Dietary supplementPlacebo 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.
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.
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.
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.
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.
Change in Family Quality of Life
Change in family Quality of Life (QoL), assessed by the Pediatric Quality of Life Inventory™ Family Impact Module (PedsQL™ Family Impact Module), in the L. reuteri group compared to the placebo group. The range of the total score is 0-100 with a higher score indicating a better outcome.
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 total score range 33-99. A higher score indicates worse outcome and the cut-off of a total score of 41 or higher indicating potential sleep problems.
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.
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
This trial is not recruiting at the moment. You can still explore other options:
