Actively Recruiting
The Effect of a Multispecies Probiotics on Autism Symptoms in Children
Led by Medical University of Warsaw · Updated on 2026-01-08
110
Participants Needed
3
Research Sites
103 weeks
Total Duration
On this page
Sponsors
M
Medical University of Warsaw
Lead Sponsor
W
Winclove Probiotics B.V.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Effect of a Multispecies Probiotics on Autism Symptoms in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Autism Spectrum Disorder (ASD) according to DSM-5 or ICD-10
- Children not taking any medication or on the same medication for at least 2 months
- Willingness of patients or their caregivers to provide written informed consent
- Commitment to use nutritional supplements for 3 months during the trial
- Agreement to not start any special diet during the study
- Ability to complete questionnaires at baseline and after 12 weeks
You will not qualify if you...
- Use of antibiotics (except topical) within 2 months before enrollment
- Use of probiotics or synbiotics within 2 months before enrollment
- History of intolerance or allergy to probiotics, synbiotics, or any study product components
- History of bowel surgery with resection or diagnosis of short bowel syndrome
- Severe immunodeficiency in the child
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Department of Paediatrics, The Medical University of Warsaw
Warsaw, Warsaw, Poland, 02-091
Actively Recruiting
2
Department of Paediatrics, The Medical University of Warsaw
Warsaw, Warsaw, Poland, 02-091
Actively Recruiting
3
Department of Paediatrics, The Medical University of Warsaw
Warsaw, Warsaw, Poland, 02-091
Actively Recruiting
Research Team
M
Maja Kotowska, MD
CONTACT
J
Jan Łukasik, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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