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| Name | Class |
|---|---|
| SENAI CIMATEC | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mix Probiotic K11T with out vitamins | Active Comparator | Drug-1: K11T 1 dose/day Orally |
|
| Mix Probiotic K11TMAX with vitamins | Active Comparator | Drug-1: K11Tmax 1 dose/day Orally |
|
| Placebo drugs | Placebo Comparator | Placebo 1 dose/day Orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inflammatory level | Dietary Supplement | Quantification of C-reactive Protein (PCR) Quantification of serum cortisol Insulin quantification Prolactin quantification Fecal calprotectin dosage |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammation biomarker 1 | Quantify inflammatory markers through blood collection: Quantification of C-reactive Protein (CRP) - results in mg/dL | 90 days (Day 0, Day 45 and Day 90) |
| Inflammation biomarker 2 | Quantify inflammatory markers through blood collection: Serum Cortisol Quantification - results will be expressed in mcg/dL; | 90 days (Day 0, Day 45 and Day 90) |
| Inflammation biomarker 3 | Quantify inflammatory markers through blood collection: Insulin Quantification - the results will be expressed in mcUI/ml; | 90 days (Day 0, Day 45 and Day 90) |
| Inflammation biomarker 4 | Quantify inflammatory markers through blood collection: Prolactin Quantification - results will be expressed in ng/dL | 90 days (Day 0, Day 45 and Day 90) |
| Inflammation biomarker 5 | Quantify inflammatory markers through blood collection: Fecal Calprotectin Measurement - expressed in μg/g | 90 days (Day 0, Day 45 and Day 90) |
| Neuropsychological Assessment | involves a multidisciplinary approach, considering different aspects of neuropsychological functioning. Standardized analysis will be conducted using the Vineland Adaptive Behavior Scales - Vineland-3. The forms will be completed in their self-administered version by parents/caregivers and teachers, under the supervision of a qualified and trained health professional. Vineland-3 assesses adaptive behavior by dividing it into five domains: communication skills, daily living skills, socialization skills, motor skills and maladaptive/behavioral skills of the child. Those responsible will respond to the items in each domain on a scale ranging from 0 to 2, with 0 being never; 1 sometimes and 2 often. To calculate the final score, the scores are transformed into a population average of 100 based on age and a standard deviation of 15 according to the specific and standardized manual for the scale. A higher score indicates greater adaptive functioning. |
| Measure | Description | Time Frame |
|---|---|---|
| Psychiatric Assessment | The ADOS-2 (Autism Diagnostic Observation Schedule, Second Edition) observational assessment will be applied. This is a standardized assessment that involves direct observation of the child in different situations and social interactions. The evaluated parameters are divided into 5 items according to the psychiatric criteria for ASD diagnoses by the Diagnostic and Statistical Manual of Mental Disorders (DSM): language and communication; reciprocal social interaction; play and imagination; stereotypical behaviors and restricted interests and, finally, atypical behaviors. The observation lasts 60 minutes and will be carried out by trained and qualified professionals supervised by a reference neuropsychologist. After applying the ADOS, the domains are coded on a scale that varies from 0 to 3 points, where 0 indicates that the child has a certain ability and 3 indicates abnormal or dysfunctional behavior. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparative of outcomes between arm that took K11-T and arm that took K11-Tmax. | Comparative of all outcomes from arm k11-T and K11-Tmax. Results will be expressed in %. | 90 days (Day 0, Day 45 and Day 90) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deivis O Guimaraes, PhD student | GON1 P&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gon1 gestora de Projetos | Vitória | Espírito Santo | 29050335 | Brazil | ||
| Gon1 P&D |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41547752 | Derived | de Queiroz SAL, Guimaraes DO, Ferreira LA, Martinelli L, Werly RMM, Amorim RF, Holzbach LBSS, Badaro R, Santos AAB, Vasquez EC, Silva RS. Kefir-derived probiotic mixture for children with autism spectrum disorder: a double-blind randomized clinical trial. BMC Pediatr. 2026 Jan 17;26(1):186. doi: 10.1186/s12887-026-06515-0. |
| Label | URL |
|---|---|
| International Contract Research Organization | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 22, 2024 | Apr 18, 2024 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 22, 2024 | Apr 16, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| ID | Term |
|---|---|
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000073216 | Mental Status and Dementia Tests |
| ID | Term |
|---|---|
| D009483 | Neuropsychological Tests |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
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Double blind, randomized, with placebo control
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| Cognitive assessment | Dietary Supplement | Neurological assessment Psychiatric assessment |
|
| Pedagogical assessment | Dietary Supplement | Sociopedagogical assessment |
|
| 90 days (Day 0, Day 45 and Day 90) |
| 90 days (Day 0, Day 45 and Day 90) |
| Psychopedagogical Assessment | Will be carried out using a questionnaire validated in literature in the version translated into Portuguese, called the Childhood Autism Rating Scale (CARS). It consists of a scale with fifteen parameters on the symptoms of autism spectrum disorder in children, which include: interpersonal relationships, imitation, emotional response, body use, use of objects, response to changes, visual response, auditory response, response and use of taste, smell and touch, fear or nervousness, verbal communication, non-verbal communication, level of activity, level and consistency of intellectual response and finally a general parameter of that individual's autism. Variations from 1 to 4, with number 1 corresponding to no difficulty in performing that skill until 4 being severe difficulty. If you are between 15 and 30 years old, you do not have autism; 30 to 36 mild to moderate autism and 36 to 60 correspond to severe autism. | 90 days (Day 0, Day 45 and Day 90) |
| Vitória |
| Espírito Santo |
| 29050335 |
| Brazil |
| Ethics and research committee | View source |