NCT06448767Recruiting
The Effect of a Multispecies Probiotics on Autism Symptoms in Children
Source: ClinicalTrials.gov · Last updated 8 Jan 2026
Brief summary (registry, in English)
In this trial, the investigators aim to evaluate the impact of a multispecies probiotic consisting of Bacillus subtilis W201, Bifidobacterium infantis W17, Bifidobacterium lactis W51, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus rhamnosus W140, Lactococcus lactis W19, Propionibacterium freudenreichii W200, on the severity of autism symptoms, quality of life, gastrointestinal symptoms, sleep disturbances, parental stress levels and urinary p-cresol concentrations in children with Autism Spectrum Disorder aged 7 to 15 years.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 3 Jun 2024
- Start date
- 7 Aug 2024
- Primary completion date
- Jul 2026
- Lead sponsor
- Medical University of Warsaw
- Diseases
- Autism
- NCT number
- NCT06448767
What you commit to
- Study type: Interventional
- Planned participants: 110
- From 7 Aug 2024 to the primary completion date, Jul 2026
- 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
- Use of antibiotics in the previous 2 months before enrolling (excluding topical antibiotics).
- Use of probiotics or synbiotics within the previous 2 months.
Other illness
- History of intolerance or allergy to probiotics, synbiotics or any other study product component.
- Surgery with bowel resection or short bowel syndrome.
Other
- Children with severe immunodeficiency.
Who the study is looking for
- Diagnosis of ASD according to the Diagnostic and Statistical Manual of Mental Disorders, the fifth edition (DSM-5) or International Classification of Diseases, Tenth Revision (ICD-10).
- Children either not taking any medication or receiving the same medication for the last 2 months.
- Patients, or their parents/caregivers, are willing to provide written informed consent, proceed with nutritional supplements throughout the 3-month trial, refrain from starting any kind of special diet for the duration of the study, and complete the questionnaires at two time points during the study.
Age in the registry: 7 years to 15 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 |
|---|---|---|---|
| Department of Paediatrics, The Medical University of Warsaw Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
Related publications
- Effect of multispecies probiotics on autism symptoms: protocol for a randomized controlled trial (PROBAUT).Trials · 2025 · PMID 41422017
This page is information, not medical advice. Discuss any trial with your doctor.