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Effect of Probiotic Compound K11T e K11TMax in ASD - Trial NCT06382909

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.

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NCT06382909
Recruitment Completed
dietary supplement
Trial Details
ClinicalTrials.gov โ€ข NCT06382909
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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

Study Focus

Autism Spectrum Disorder

Inflammatory level

Interventional

dietary supplement

Sponsor & Location

Deivis de Oliveira guimaraes

Gon1 Gestao de Projetos

Vitoria,Vitรณria, Brazil

Timeline & Enrollment

N/A

Mar 22, 2024

Apr 07, 2025

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 autism
Atypical autism
Asperger syndrome
Neurotic disorder, unspecified
Mental and behavioural disorders

Data Source

ClinicalTrials.gov

NCT06382909

Non-Device Trial