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NCT06382909

Effect of Probiotic Compound K11T e K11TMax in ASD

Effects of the Probiotic k11-tmax on Symptoms and Inflammatory Markers in Children With Autism Spectrum Disorder
Deivis de Oliveira guimaraes·ClinicalTrials.gov·dietary supplementRecruitment Completed
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Study focus
Disease/Condition
Autism Spectrum Disorder
Drug/Device/Intervention
Inflammatory level
Study type
Interventional
Intervention type
dietary supplement
Sponsor & location
Primary sponsor
Deivis de Oliveira guimaraes
Funder
Gon1 Gestao de Projetos
Location
Vitoria,Vitória, Brazil
Timeline & enrollment
Phase
N/A
Start date
Mar 22, 2024
End date
Apr 07, 2025
Enrollment
505 participants
Primary outcome

Inflammation biomarker 1,Inflammation biomarker 2,Inflammation biomarker 3,Inflammation biomarker 4,Inflammation biomarker 5,Neuropsychological Assessment

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.

ICD-10 classifications
Childhood autismAtypical autismAsperger syndromeNeurotic disorder, unspecifiedMental and behavioural disorders
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06382909
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06382909 through Pure Global AI's free database. This phase not specified trial is sponsored by Deivis de Oliveira guimaraes and is currently Recruitment Completed. The study focuses on Autism Spectrum Disorder. Target enrollment is 505 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.