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| Name | Class |
|---|---|
| Winclove Probiotics B.V. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multispecies probiotics group | Experimental | 55 participants |
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| Control group | Placebo Comparator | 55 participants |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multispecies probiotics | Dietary Supplement | Multispecies probiotics 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 at a dose of 5x10^9 Colony Forming Units (CFU), once daily, orally. |
| Measure | Description | Time Frame |
|---|---|---|
| The Autism Spectrum Rating Scales (ASRS) | Assessment of the severity of ASD symptoms. Scores are reported as percentiles, with higher values indicating greater symptom severity. | 0-3 months |
| Measure | Description | Time Frame |
|---|---|---|
| The Parenting Stress Index, 4th Edition (PSI-4) / SIPA (Stress Index for Parents of Adolescents) | Assessment of the parenting stress intensity. The level of parental stress will be assessed using the PSI-4 questionnaire if the child is under 11 years old, or the SIPA if the child is 11 years or older. Scores range from 101 to 505 points for the PSI-4 and 90 to 450 points for the SIPA. Higher scores indicate higher level of stress. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maja Kotowska, MD | Contact | +48223179536 | kotowska.maja@gmail.com | |
| Jan Łukasik, MD, PhD | Contact | +48223179536 | jan.lukasik@wum.edu.pl |
| Name | Affiliation | Role |
|---|---|---|
| Maja Kotowska, MD | Department of Paediatrics, The Medical University of Warsaw, Poland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Paediatrics, The Medical University of Warsaw | Recruiting | Warsaw | Warsaw | 02-091 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41422017 | Derived | Kotowska-Babol M, Konowalek L, Szajewska H, Lukasik J. Effect of multispecies probiotics on autism symptoms: protocol for a randomized controlled trial (PROBAUT). Trials. 2025 Dec 20;26(1):573. doi: 10.1186/s13063-025-09373-w. |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Placebo | Other | Placebo identical in taste, smell and color to the multispecies probiotics. |
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| 0-3 months |
| Children Sleep Habit Questionnaire - Abbreviated (CSHQ-A) | Assessment of the sleep impairments. Scores range from 0 to 154 points, with higher values indicating a greater severity of sleep disturbances. | 0-3 months |
| The Quality of Life in Autism Part A (QoLA-A) | Assessment of the quality of life of parents of children with ASD. Scores range from 28 to 140 points, with higher values reflecting a better quality of life. | 0-3 months |
| Gastrointestinal Symptom Rating Scale (GSRS) | Assessment of the severity of gastrointestinal symptoms. Scores range from 15 to 105 points, with higher values indicating greater severity of gastrointestinal symptoms. | 0-3 months |
| P-cresol levels in urine samples | Assessment of the level of p-cresol in urine samples. | 0-3 months |
| Department of Paediatrics, The Medical University of Warsaw | Recruiting | Warsaw | Warsaw | 02-091 | Poland |
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| Department of Paediatrics, The Medical University of Warsaw | Recruiting | Warsaw | Warsaw | 02-091 | Poland |
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