NCT06448767 The Effect of a Multispecies Probiotics on Autism Symptoms in Children
| NCT ID | NCT06448767 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Warsaw |
| Condition | Autism Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2024-08-07 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 110 participants in total. It began in 2024-08-07 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Maja Kotowska, MD
PRINCIPAL INVESTIGATOR
Department of Paediatrics, The Medical University of Warsaw, Poland
Frequently Asked Questions
Who can join the NCT06448767 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, up to 15 Years, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06448767 currently recruiting?
Yes, NCT06448767 is actively recruiting participants. Contact the research team at kotowska.maja@gmail.com for enrollment information.
Where is the NCT06448767 trial being conducted?
This trial is being conducted at Warsaw, Poland, Warsaw, Poland, Warsaw, Poland.
Who is sponsoring the NCT06448767 clinical trial?
NCT06448767 is sponsored by Medical University of Warsaw. The principal investigator is Maja Kotowska, MD at Department of Paediatrics, The Medical University of Warsaw, Poland. The trial plans to enroll 110 participants.