Identification of Risk Predictors for SARS-CoV-2 Infection Based on the Microbiome of School-age Children and Their Family Members (PREDICOL)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 932
- 试验地点
- 1
- 主要终点
- Relative abundance of intestinal microbial taxa associated with SARS-CoV-2 infection
研究概览
简要总结
The goal of this observational cohort study is to evaluate the association between gut microbiota composition, dietary patterns, lifestyle-related factors, and neurodevelopmental outcomes, as well as susceptibility to SARS-CoV-2 infection, in a predominantly school-aged population and their adult contacts (family and teachers).
This study aims to answer the following main questions:
- Are specific gut microbiota profiles and dietary patterns associated with cognitive and behavioral development in non-clinical children and adolescents?
- Can baseline gut microbiota and lifestyle-related factors be associated with susceptibility to SARS-CoV-2 infection during the pandemic period?
The cohort includes more than 900 participants recruited between November and December 2020 in Valencia, Spain, including children and adolescents (approximately 3-19 years of age), as well as their family members and teachers. The cohort is structured into two predefined subcohorts. One subcohort includes children and adolescents and focuses on neurodevelopmental outcomes. The second subcohort includes both pediatric and adult participants and is used to evaluate gut microbiota-related factors in relation to SARS-CoV-2 infection.
Study assessments include stool sample collection for gut microbiota analysis, dietary assessment using validated food frequency questionnaires, and collection of sociodemographic, clinical, anthropometric, lifestyle, and health-related information through standardized questionnaires. Cognitive and behavioral outcomes in children and adolescents are assessed using validated instruments.
The study includes an initial cross-sectional assessment followed by a longitudinal follow-up over a 17-month period. During follow-up, stool samples were collected from participants who became infected with SARS-CoV-2 at different stages of the infection. At the end of the follow-up period, biological samples and study assessments were repeated when available.
The results of this study are expected to contribute to the identification of microbial, dietary, and lifestyle-related biomarkers associated with neurodevelopment and susceptibility to infectious diseases, supporting the development of preventive and non-pharmacological public health strategies.
详细描述
Two predefined subcohorts were established. The first subcohort includes 407 children and adolescents and focuses on exploring associations between gut microbiota, diet, lifestyle factors, and cognitive and behavioral development in individuals without clinically diagnosed disorders. The second subcohort includes pediatric and adult participants and aims to evaluate whether baseline gut microbiota and related factors are associated with SARS-CoV-2 infection during the follow-up period.
The study follows an observational design with a baseline cross-sectional assessment and a longitudinal follow-up of 17 months. Biological samples and health-related information were collected to characterize gut microbiota profiles and to evaluate their relationship with developmental, behavioral, and infectious outcomes over time.
Cognitive and behavioral outcomes were assessed using validated instruments, including the Behavior Rating Inventory of Executive Function (BRIEF), the Strengths and Difficulties Questionnaire (SDQ), and diagnostic criteria from the Diagnostic and Statistical Manual of Mental Disorders (DSM-V). Gut microbiota composition was characterized by shotgun metagenomic sequencing of stool samples collected using standardized procedures.
Dietary intake was assessed using a validated 137-item semi-quantitative food frequency questionnaire, allowing estimation of daily intake of food groups and nutrients. Dietary quality and inflammatory potential were evaluated using the Dietary Inflammatory Index, adherence to the Mediterranean Diet, and the Spanish Healthy Eating Index.
By integrating microbiota, dietary, lifestyle, and developmental data, this study aims to identify microbial and lifestyle-related biomarkers associated with early neurodevelopmental trajectories and susceptibility to viral infections, supporting the development of preventive and non-pharmacological public health strategies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be over 3 years of age.
- •Complete all questionnaires on diet, lifestyle, health, etc.
- •Ability to give written consent; in the case of minors, have the consent of a legal guardian.
排除标准
- •History of confirmed SARS-CoV-2 infection, positive serology (IgM/IgG).
- •NOT have any minors living with them in the study.
结局指标
主要结局
Relative abundance of intestinal microbial taxa associated with SARS-CoV-2 infection
时间窗: Baseline (at enrollment).
Relative abundance of bacterial taxa in fecal samples determined by shotgun metagenomic sequencing and analyzed as predictors of SARS-CoV-2 infection risk. Associations between microbial features and infection status will be assessed using odds ratios and other risk estimation models.
次要结局
- Learning difficulties assessed by DSM-5 criteria(Baseline (at enrollment))
- Dietary pattern adherence score derived from principal component analysis(Baseline (at enrollment))
- Compliance with age- and sex-specific dietary recommendations(Baseline (at enrollment))
- Daily food group intake assessed by EPIC Food Frequency Questionnaire (grams/day)(Baseline (at enrollment))
- Daily nutrient intake assessed by EPIC Food Frequency Questionnaire (grams/day)(Baseline (at enrollment))
- Executive function assessed by Behavior Rating Inventory of Executive Function (BRIEF) T-score(Baseline (at enrollment))
- Total difficulties score assessed by Strengths and Difficulties Questionnaire (SDQ)(Baseline (at enrollment))
- Daily stress level assessed by Inventario de Estrés Cotidiano Infantil (IECI)(Baseline (at enrollment))
研究者
Yolanda Sanz Herranz
Professor
Spanish National Research Council