Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06382909
Status:
COMPLETED
Last Update Posted:
2024-04-29
First Post:
2024-03-28
Brief Title:
Effect of Probiotic Compound K11T e K11TMax in ASD
Sponsor:
Deivis de Oliveira guimaraes
Organization:
Gon1 Gestao de Projetos
Study Overview
Official Title:
Effects of the Probiotic k11-tmax on Symptoms and Inflammatory Markers in Children With Autism Spectrum Disorder
Status:
COMPLETED
Status Verified Date:
2024-10
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:
ASD
Brief Summary:
The research is characterized as a randomized double-blind clinical trial phase III in which administered the probiotic K11-T with and without added amino acids fatty acids and vitamins to children between 3 and 11 years old with Autism Spectrum Disorder - ASD being subsequently assessed outcomes related to inflammatory markers and neuropsychiatric and sociopedagogical criteria To this end the study will create three groups one of which will be a control group which will receive a placebo the other will receive the probiotic without micronutrients and another will receive the probiotic with added nutrients
Detailed Description:
To evaluate the effectiveness of probiotic compounds K11-T and K11-Tmax enriched with amino acids acids fatty acids and vitamins in its solid and nano-encapsulated formulation to improve the criteria neuropsychiatric sociopedagogical and inflammatory disorders in children with ASD
Secondary
Characterize the sample of individuals with ASD who will participate in the study through a questionnaire with sociodemographic and pedagogical data such as Age in years gender in percentage terms of the sample according to female or male Weight in kg Height in centimeters Time since diagnosis of ASD in years and presence of psychiatric or neurological comorbidities in percentage terms of the sample
Investigate the association between probiotic consumption and neuropsychological results using the scale unit validated in the literature Vineland Adaptive Behavior Scales - Third Edition Vineland-3 in the questionnaire format answered by parentsguardians of the child with ASD
Investigate the association between probiotic consumption and the change of psychiatric parameters through the application of the validated Autism Diagnostic Observation Schedule ADOS scale with children with ASD
Investigate the association between probiotic consumption and the change of psychopedagogical parameters using the Childhood Autism Rating Scale CARS validated in the literature which will be answered by the teachers responsible for each child participating in the study
Analyze the possible effect of probiotics on inflammatory aspects in individuals with ASD through serum Insulin C-Reactive Protein Prolactin and Cortisol and fecal fecal calprotectin biomarkers
Analyze the difference of using the K11-Tmax version enriched with supplements on the neuropsychological psychiatric and psychopedagogical outcomes described above in comparison to the group that used K11-Tmax alone
Secondary
Characterize the sample of individuals with ASD who will participate in the study through a questionnaire with sociodemographic and pedagogical data such as Age in years gender in percentage terms of the sample according to female or male Weight in kg Height in centimeters Time since diagnosis of ASD in years and presence of psychiatric or neurological comorbidities in percentage terms of the sample
Investigate the association between probiotic consumption and neuropsychological results using the scale unit validated in the literature Vineland Adaptive Behavior Scales - Third Edition Vineland-3 in the questionnaire format answered by parentsguardians of the child with ASD
Investigate the association between probiotic consumption and the change of psychiatric parameters through the application of the validated Autism Diagnostic Observation Schedule ADOS scale with children with ASD
Investigate the association between probiotic consumption and the change of psychopedagogical parameters using the Childhood Autism Rating Scale CARS validated in the literature which will be answered by the teachers responsible for each child participating in the study
Analyze the possible effect of probiotics on inflammatory aspects in individuals with ASD through serum Insulin C-Reactive Protein Prolactin and Cortisol and fecal fecal calprotectin biomarkers
Analyze the difference of using the K11-Tmax version enriched with supplements on the neuropsychological psychiatric and psychopedagogical outcomes described above in comparison to the group that used K11-Tmax alone
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