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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 505 (actual)
• Sponsor: Deivis de Oliveira guimaraes · Network
• Sex: All
• Age: 3 Years – 11 Years
• Healthy volunteers: Not accepted

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 parents/guardians 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.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-03-22
• Primary completion: 2024-07-07
• Completion: 2024-08-07
• First posted: 2024-04-24
• Last updated: 2024-10-03

Locations

2 sites across 1 country: Brazil