Clinical trial NCT06382909: Effect of Probiotic Compound K11T e K11TMax in ASD
Official title: Effects of the Probiotic k11-tmax on Symptoms and Inflammatory Markers in Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: intestinal inflammatory
cognitive
probiotics
asd
Gut Microbiota
Biomarkers
Lead sponsor: Gon1 Gestao de Projetos
Sponsor class: NETWORK
Collaborators: name: SENAI CIMATEC
First posted: 2024-04-24
Enrollment: 505
Sex: ALL
Minimum age (years): 3
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind, randomized, with placebo control
Primary purpose: SUPPORTIVE_CARE

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 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.

Eligibility criteria: Inclusion Criteria:

* Volunteers must have a confirmed diagnosis of ASD carried out by qualified professionals, in accordance with the criteria established in the Diagnostic Manual and Statistics of Mental Disorders (DSM-5) or other diagnostic classification recognized.
* The study will include children and adolescents in the specific age range of 3 to 11years.
* Be regularly enrolled in a public or private school, or in a learning center special education.
* Absence of decompensated clinical or psychiatric comorbidities;
* Informed consent: Legal guardians must provide a informed consent, understanding the study objectives, procedures involved, the risks and benefits, as well as the freedom to withdraw from the study at any time. anytime.
* Informed Assent: Children ages 7 to 11 must provide an informed consent, understanding the objectives of the study, the procedures involved, the risks and benefits, as well as the freedom to withdraw from the study at any time. anytime.

Exclusion Criteria:

* - Concomitant restrictive medical conditions that may interfere with the results of the study, such as serious gastrointestinal diseases, significant metabolic diseases or immunodeficiencies.
* Use of specific medications such as broad-spectrum antibiotics or immunosuppressive medications during the follow-up period.
* Allergies or intolerances to components of the probiotics that will be administered.
* Previous or current participation in recent clinical studies with interventions different therapies.
* Uncontrolled heart conditions or serious unstable medical illnesses.
* Impossibility of being present on the pre-determined assessment dates clinics.

Primary outcomes:
measure: Inflammation biomarker 1
timeFrame: 90 days (Day 0, Day 45 and Day 90)
measure: Inflammation biomarker 2
timeFrame: 90 days (Day 0, Day 45 and Day 90)
measure: Inflammation biomarker 3
timeFrame: 90 days (Day 0, Day 45 and Day 90)
measure: Inflammation biomarker 4
timeFrame: 90 days (Day 0, Day 45 and Day 90)
measure: Inflammation biomarker 5
timeFrame: 90 days (Day 0, Day 45 and Day 90)
measure: Neuropsychological Assessment
timeFrame: 90 days (Day 0, Day 45 and Day 90)
Secondary outcomes:
measure: Psychiatric Assessment
timeFrame: 90 days (Day 0, Day 45 and Day 90)
measure: Psychopedagogical Assessment
timeFrame: 90 days (Day 0, Day 45 and Day 90)
Other outcomes:
measure: Comparative of outcomes between arm that took K11-T and arm that took K11-Tmax.
timeFrame: 90 days (Day 0, Day 45 and Day 90)
Locations:
city: Vitoria
country: Brazil
facility: Gon1 P&D
state: ES
city: Vitória
country: Brazil
facility: Gon1 gestora de Projetos
state: ES
Study officials:
affiliation: GON1 P&D
name: Deivis O Guimaraes, PhD student
role: STUDY_DIRECTOR
References: