The Effect of a Multispecies Probiotics on Autism Symptoms in Children
Overview
- Phase
- N/A
- Intervention
- Multispecies probiotics
- Conditions
- Autism Spectrum Disorder
- Sponsor
- Medical University of Warsaw
- Enrollment
- 110
- Locations
- 2
- Primary Endpoint
- The Autism Spectrum Rating Scales (ASRS)
- Status
- Recruiting
- Last Updated
- 3 months ago
Overview
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.
Detailed Description
This study is a randomized, double-blind, placebo-controlled clinical trial. One hundred and ten children aged 7 to 15 years diagnosed with Autism Spectrum Didorder will be randomly assigned in a 1:1 ratio to receive either a multispecies probiotics or a placebo for 12 weeks. The probiotic mixture contains 5 x 10\^9 colony forming units per dose 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. The primary outcome will be the assessment of core autism symptoms using the Autism Symptom Rating Scales (ASRS). The secondary outcomes will include: the quality of life measured by the Quality of Life in Autism Part A questionnaire (QoLA-A), evaluations of sleep impairments using Children Sleep Habit Questionnaire - Abbreviated (CSHQ-A), parental stress levels using Parenting Stress Index-III (PSI-III), gastrointestinal symptoms using Gastrointestinal Symptom Rating Scale (GSRS), and urinary p-cresol levels. These outcomes will be assessed twice: at baseline and after 12 weeks of intervention.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
- •Children with severe immunodeficiency.
Arms & Interventions
Multispecies probiotics group
55 participants
Intervention: Multispecies probiotics
Control group
55 participants
Intervention: Placebo
Outcomes
Primary Outcomes
The Autism Spectrum Rating Scales (ASRS)
Time Frame: 0-3 months
Assessment of the severity of ASD symptoms. Scores are reported as percentiles, with higher values indicating greater symptom severity.
Secondary Outcomes
- The Parenting Stress Index, 4th Edition (PSI-4) / SIPA (Stress Index for Parents of Adolescents)(0-3 months)
- Children Sleep Habit Questionnaire - Abbreviated (CSHQ-A)(0-3 months)
- The Quality of Life in Autism Part A (QoLA-A)(0-3 months)
- Gastrointestinal Symptom Rating Scale (GSRS)(0-3 months)
- P-cresol levels in urine samples(0-3 months)