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Effect of Probiotic Compound K11T e K11TMax in ASD

NCT06382909 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 505

Last updated 2024-10-03

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Inflammatory level

Quantification of C-reactive Protein (PCR) Quantification of serum cortisol Insulin quantification Prolactin quantification Fecal calprotectin dosage

DIETARY_SUPPLEMENT

Cognitive assessment

Neurological assessment Psychiatric assessment

DIETARY_SUPPLEMENT

Pedagogical assessment

Sociopedagogical assessment

Sponsors & Collaborators

  • SENAI CIMATEC

    collaborator OTHER

  • Deivis de Oliveira guimaraes

    lead NETWORK

Principal Investigators

  • Deivis O Guimaraes, PhD student · GON1 P&D

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-22
Primary Completion
2024-07-07
Completion
2024-08-07

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06382909 on ClinicalTrials.gov