Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
505 participants
INTERVENTIONAL
2024-03-22
2024-08-07
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Mix Probiotic K11T with out vitamins
Drug-1: K11T
1 dose/day Orally
Inflammatory level
Quantification of C-reactive Protein (PCR) Quantification of serum cortisol Insulin quantification Prolactin quantification Fecal calprotectin dosage
Cognitive assessment
Neurological assessment Psychiatric assessment
Pedagogical assessment
Sociopedagogical assessment
Mix Probiotic K11TMAX with vitamins
Drug-1: K11Tmax
1 dose/day Orally
Inflammatory level
Quantification of C-reactive Protein (PCR) Quantification of serum cortisol Insulin quantification Prolactin quantification Fecal calprotectin dosage
Cognitive assessment
Neurological assessment Psychiatric assessment
Pedagogical assessment
Sociopedagogical assessment
Placebo drugs
Placebo
1 dose/day Orally
Inflammatory level
Quantification of C-reactive Protein (PCR) Quantification of serum cortisol Insulin quantification Prolactin quantification Fecal calprotectin dosage
Cognitive assessment
Neurological assessment Psychiatric assessment
Pedagogical assessment
Sociopedagogical assessment
Interventions
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Inflammatory level
Quantification of C-reactive Protein (PCR) Quantification of serum cortisol Insulin quantification Prolactin quantification Fecal calprotectin dosage
Cognitive assessment
Neurological assessment Psychiatric assessment
Pedagogical assessment
Sociopedagogical assessment
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
3 Years
11 Years
ALL
No
Sponsors
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SENAI CIMATEC
OTHER
Deivis de Oliveira guimaraes
NETWORK
Responsible Party
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Deivis de Oliveira guimaraes
Director of Research
Principal Investigators
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Deivis O Guimaraes, PhD student
Role: STUDY_DIRECTOR
GON1 P&D
Locations
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Gon1 gestora de Projetos
Vitória, Espírito Santo, Brazil
Gon1 P&D
Vitória, Espírito Santo, Brazil
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Related Links
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International Contract Research Organization
Ethics and research committee
Other Identifiers
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202302
Identifier Type: -
Identifier Source: org_study_id
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