The Effect of a Multispecies Probiotics on Autism Symptoms in Children
ConditionAutism Spectrum Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-15
SponsorMedical University of Warsaw
About this trial
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
Qualifiers
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.
Disqualifiers
Use of antibiotics in the previous 2 months before enrolling (excluding topical antibiotics).
Use of probiotics or synbiotics within the previous 2 months.
History of intolerance or allergy to probiotics, synbiotics or any other study product component.
Surgery with bowel resection or short bowel syndrome.
Trial design
Treatments tested in this trial
- Multispecies probiotics
- Placebo
Treatment groups
110 Participants
are divided into 2 treatment groupsSponsors and collaborators
Medical University of Warsaw
Lead sponsor
Winclove Probiotics B.V.
Collaborator
Source ClinicalTrials.gov