Evaluating probiotics for autism symptoms and quality of life in children
Official title: The Effect of a Multispecies Probiotics on Autism Symptoms in Children
Run by Medical University of Warsaw · NCT06448767 · Data updated 2026-11-12
This study is testing if a special probiotic can help improve autism symptoms and quality of life for children aged 7 to 15 with Autism Spectrum Disorder.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 7 Years to 15 Years |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | Medical University of Warsaw Academic / other |
| Locations | 3 sites (Warsaw, Warsaw and 2 other locations) |
| Status | Recruiting |
| Started | August 7, 2024 |
| Main results expected | July 2026 |
| Study ends | July 30, 2026 |
| Registry record updated | January 8, 2026 |
| Trial ID | NCT06448767 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 7 to 15 with a diagnosis of Autism Spectrum Disorder who meet specific inclusion criteria.
✕Probably not a fit
Patients who have recently used antibiotics or probiotics, have severe immunodeficiency, or have a history of intolerance to probiotics may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effects of a multispecies probiotic on children aged 7 to 15 diagnosed with Autism Spectrum Disorder (ASD). In a randomized, double-blind, placebo-controlled design, 108 participants will receive either the probiotic or a placebo for 12 weeks. The study aims to assess core autism symptoms and quality of life using validated questionnaires, alongside secondary outcomes related to sleep, parental stress, gastrointestinal symptoms, and urinary p-cresol levels. Assessments will occur at baseline and after the intervention period to evaluate changes in these outcomes.
Why it matters
Potential benefit: If successful, this study could provide a novel therapeutic option to improve autism symptoms and enhance the quality of life for affected children.
How similar studies have gone: While the use of probiotics in autism is an emerging area, previous studies have shown promising results, suggesting potential benefits in similar approaches.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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). 2. Children either not taking any medication or receiving the same medication for the last 2 months. 3. 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. Exclusion Criteria: 1. Use of antibiotics in the previous 2 months before enrolling (excluding topical antibiotics). 2. Use of probiotics or synbiotics within the previous 2 months. 3. History of intolerance or allergy to probiotics, synbiotics or any other study product component. 4. Surgery with bowel resection or short bowel syndrome. 5. Children with severe immunodeficiency.
Where it's running
-
Department of Paediatrics, The Medical University of Warsaw
Warsaw, Warsaw, Poland Recruiting -
Department of Paediatrics, The Medical University of Warsaw
Warsaw, Warsaw, Poland Recruiting -
Department of Paediatrics, The Medical University of Warsaw
Warsaw, Warsaw, Poland Recruiting
Study contacts
- Principal investigator: Maja Kotowska, MD — Department of Paediatrics, The Medical University of Warsaw, Poland
- Study coordinator: Maja Kotowska, MD
- Email: kotowska.maja@gmail.com
- Phone: +48223179536
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.