Tests a probiotic for social difficulties in children with autism
Compares a probiotic with a placebo in children aged 4 to 12 with autism.
Plain-language title generated from the registry record
Registry title: Effect of Limosilactobacillus Reuteri on Social Deficits in Children With Autistic Spectrum Disorder
Key facts
- Where
- Mendoza, ArgentinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 4 and 12 years old?
Source: NCT07845253, who can take part
Where in Argentina
- Sanatorio MaipúMendoza, ArgentinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- BioGaia AB
- Trial code
- NCT07845253
- Record updated
- 30 September 2026
- Original description
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 full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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); 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; Participation in other interventional clinical study.