Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06448767
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-03
Brief Title:
The Effect of a Multispecies Probiotics on Autism Symptoms and the Quality of Life in Children
Sponsor:
Medical University of Warsaw
Organization:
Medical University of Warsaw
Study Overview
Official Title:
The Effect of a Multispecies Probiotics on Autism Symptoms and the Quality of Life in Children
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROBAUT
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 and the quality of life in children with Autism Spectrum Disorder aged 7 to 15
Detailed Description:
This study is a randomized double-blind placebo-controlled clinical trial One hundred and eight children aged 7 to 15 years diagnosed with Autism Spectrum Didorder will be randomly assigned in a 11 ratio to receive either a multispecies probiotics or a placebo for 12 weeks The probiotic mixture contains 5 x 109 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 two co-primary outcomes will be the assessment of core autism symptoms using the Autism Symptom Rating Scales ASRS and quality of life measured by the Quality of Life in Autism Part A questionnaire QoLA-A The secondary outcomes will include 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
The two co-primary outcomes will be the assessment of core autism symptoms using the Autism Symptom Rating Scales ASRS and quality of life measured by the Quality of Life in Autism Part A questionnaire QoLA-A The secondary outcomes will include 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None