Effects of the Probiotic k11-tmax on Symptoms and Inflammatory Markers in Children With Autism Spectrum Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 505
- 试验地点
- 4
- 主要终点
- Inflammation biomarker 4
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •- 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.
结局指标
主要结局
Inflammation biomarker 4
时间窗: 90 days (Day 0, Day 45 and Day 90)
Quantify inflammatory markers through blood collection: Prolactin Quantification - results will be expressed in ng/dL
Inflammation biomarker 1
时间窗: 90 days (Day 0, Day 45 and Day 90)
Quantify inflammatory markers through blood collection: Quantification of C-reactive Protein (CRP) - results in mg/dL
Inflammation biomarker 2
时间窗: 90 days (Day 0, Day 45 and Day 90)
Quantify inflammatory markers through blood collection: Serum Cortisol Quantification - results will be expressed in mcg/dL;
Inflammation biomarker 3
时间窗: 90 days (Day 0, Day 45 and Day 90)
Quantify inflammatory markers through blood collection: Insulin Quantification - the results will be expressed in mcUI/ml;
Neuropsychological Assessment
时间窗: 90 days (Day 0, Day 45 and Day 90)
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.
Inflammation biomarker 5
时间窗: 90 days (Day 0, Day 45 and Day 90)
Quantify inflammatory markers through blood collection: Fecal Calprotectin Measurement - expressed in μg/g
次要结局
- Psychiatric Assessment(90 days (Day 0, Day 45 and Day 90))
- Psychopedagogical Assessment(90 days (Day 0, Day 45 and Day 90))
研究者
Deivis de Oliveira guimaraes
Director of Research
Gon1 Gestao de Projetos