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Microbiome-Based Risk Prediction of SARS-CoV-2 in Children and Families (PREDICOL) (PREDICOL)

16. července 2026 aktualizováno: Yolanda Sanz Herranz, Spanish National Research Council

Identification of Risk Predictors for SARS-CoV-2 Infection Based on the Microbiome of School-age Children and Their Family Members (PREDICOL)

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.

Přehled studie

Postavení

Dokončeno

Podmínky

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Aktuální)

932

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Španělsko
      • Valencia, Španělsko
        • Instituto de Agroquímica y Tecnología de Alimentos (IATA-CSIC)

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

Subjects over the age of 3 who are interested in participating in the study. The study targets school-aged subjects (3-17 years old) as well as their close family members and teachers.

Popis

Inclusion Criteria:

  1. Be over 3 years of age.
  2. Complete all questionnaires on diet, lifestyle, health, etc.
  3. Ability to give written consent; in the case of minors, have the consent of a legal guardian.

Exclusion Criteria:

  1. History of confirmed SARS-CoV-2 infection, positive serology (IgM/IgG).
  2. NOT have any minors living with them in the study.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
perdicol
A total of 932 participants were included in this cohort, with a higher representation of minors compared to adults. Specifically, 506 (54.3%) participants were children and adolescents, while 426 (45.7) were adults. Overall, the cohort comprised 369 family units.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Relative abundance of intestinal microbial taxa associated with SARS-CoV-2 infection
Časové okno: 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.
Baseline (at enrollment).

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Learning difficulties assessed by DSM-5 criteria
Časové okno: Baseline (at enrollment)
Learning difficulties will be evaluated according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). Participants will be classified as having no learning difficulties (0 criteria endorsed), slight learning difficulties (1-2 criteria endorsed), or significant learning difficulties (≥3 criteria endorsed). Correlations between gut microbiota characteristics and DSM-5 learning difficulty classification will be evaluated.
Baseline (at enrollment)
Dietary pattern adherence score derived from principal component analysis
Časové okno: Baseline (at enrollment)
Dietary patterns will be identified using principal component analysis (PCA) with varimax rotation based on nutrient and food group intake data. Participants will be assigned pattern adherence scores and categorized into tertiles representing low (T1), moderate (T2), and high (T3) adherence. Associations between dietary pattern adherence and gut microbiota composition will be evaluated.
Baseline (at enrollment)
Compliance with age- and sex-specific dietary recommendations
Časové okno: Baseline (at enrollment)
Participants will be classified according to compliance with Recommended Dietary Allowances (RDA) established by AESAN and the Spanish Society of Community Nutrition (SENC). Intake will be categorized as compliant, below recommendations, or above recommendations. Associations between dietary compliance and gut microbiota composition will be evaluated.
Baseline (at enrollment)
Daily food group intake assessed by EPIC Food Frequency Questionnaire (grams/day)
Časové okno: Baseline (at enrollment)
Daily intake of 22 food groups will be estimated from food frequency questionnaire data and expressed as grams per day (g/day). Food groups will be defined according to study objectives and Spanish Agency for Food Safety and Nutrition (AESAN) classification criteria. Associations between food group intake and gut microbiota composition will be evaluated.
Baseline (at enrollment)
Daily nutrient intake assessed by EPIC Food Frequency Questionnaire (grams/day)
Časové okno: Baseline (at enrollment)
Dietary intake will be assessed using a validated 137-item semi-quantitative EPIC Food Frequency Questionnaire adapted for Spanish children and adolescents. Daily intake of 52 nutrients will be estimated and expressed as grams per day (g/day). Associations between nutrient intake and gut microbiota composition will be evaluated.
Baseline (at enrollment)
Executive function assessed by Behavior Rating Inventory of Executive Function (BRIEF) T-score
Časové okno: Baseline (at enrollment)
Executive function will be assessed using the Behavior Rating Inventory of Executive Function (BRIEF). Age- and sex-adjusted T-scores will be used. Participants will be classified as normal (T<60), subclinical impairment (T=60-64), or clinical impairment (T≥65). Correlations between gut microbiota characteristics and BRIEF T-scores will be evaluated.
Baseline (at enrollment)
Total difficulties score assessed by Strengths and Difficulties Questionnaire (SDQ)
Časové okno: Baseline (at enrollment)
Behavioral and emotional difficulties will be evaluated using the Strengths and Difficulties Questionnaire (SDQ). Total difficulties scores range from 0 to 40, with higher scores indicating greater behavioral problems. Participants with scores >16 will be classified as presenting behavioral difficulties. Correlations between gut microbiota characteristics and SDQ total difficulties scores will be evaluated.
Baseline (at enrollment)
Daily stress level assessed by Inventario de Estrés Cotidiano Infantil (IECI)
Časové okno: Baseline (at enrollment)
Daily stress will be assessed using the Inventario de Estrés Cotidiano Infantil (IECI). Total questionnaire scores will be converted to age- and sex-adjusted percentiles. Participants scoring above the 70th percentile will be classified as having elevated daily stress. Correlations between gut microbiota characteristics and IECI stress scores will be evaluated.
Baseline (at enrollment)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Spanish National Research Council

Spolupracovníci

Interdisciplinary Thematic Platform (PTI+) Global Health (CSIC)

Vyšetřovatelé

  • Vrchní vyšetřovatel: Yolanda Professor Sanz, Principal Investigator, Instituto de Agroquímica y Tecnología de Alimentos (IATA-CSIC)

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. listopadu 2020

Primární dokončení (Aktuální)

30. dubna 2022

Dokončení studie (Aktuální)

22. prosince 2024

Termíny zápisu do studia

První předloženo

15. ledna 2026

První předloženo, které splnilo kritéria kontroly kvality

16. července 2026

První zveřejněno (Aktuální)

21. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

21. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

16. července 2026

Naposledy ověřeno

1. ledna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • PRE131/20

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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