NCT07845253Not yet recruiting
Effect of Limosilactobacillus Reuteri on Social Deficits in Children With Autistic Spectrum Disorder
Effect of Limosilactobacillus Reuteri on Social Deficits in Children With Autistic Spectrum Disorder: a Double-blind, Randomized, Placebo-controlled, Parallel-group Clinical Study
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 22 Sept 2026
- Start date
- Oct 2026
- Primary completion date
- Oct 2027
- Lead sponsor
- BioGaia AB
- Diseases
- Autism
- NCT number
- NCT07845253
What you commit to
- Study type: Interventional
- Planned participants: 200
- From Oct 2026 to the primary completion date, Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- 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.
Other
- Participation in other interventional clinical study.
Who the study is looking for
- 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.
Age in the registry: 4 years to 12 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sanatorio Maipú Coordinator of this site? Confirm its status | Mendoza | Argentina | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.