Heathly Subjects Susceptible to SARS-CoV-2 InfectionPREDICOLNCT07717008
Microbiome-Based Risk Prediction of SARS-CoV-2 in Children and Families (PREDICOL)
An observational study of Heathly Subjects Susceptible to SARS-CoV-2 Infection, run by Spanish National Research Council at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heathly Subjects Susceptible to SARS-CoV-2 Infection
- How many people
- 932 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2020to 22 Dec 2024
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- History of confirmed SARS-CoV-2 infection, positive serology (IgM/IgG).
- NOT have any minors living with them in the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Instituto de Agroquímica y Tecnología de Alimentos (IATA-CSIC)
Valencia
About this study
Official title: 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:
Read more
- 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.
Read the detailed description
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.
- Keywords
- Gut microbiota, Diet, SARS-CoV-2, Learning disorders, Metacognition, Behaviour
- Medical subject headings
- Learning Disabilities, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative abundance of intestinal microbial taxa associated with SARS-CoV-2 infection
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.
Measured: Baseline (at enrollment).
Secondary outcomes (8)
Learning difficulties assessed by DSM-5 criteria
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.
Measured: Baseline (at enrollment)
Dietary pattern adherence score derived from principal component analysis
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.
Measured: Baseline (at enrollment)
Compliance with age- and sex-specific dietary recommendations
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.
Measured: Baseline (at enrollment)
Daily food group intake assessed by EPIC Food Frequency Questionnaire (grams/day)
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.
Measured: Baseline (at enrollment)
Daily nutrient intake assessed by EPIC Food Frequency Questionnaire (grams/day)
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.
Measured: Baseline (at enrollment)
Executive function assessed by Behavior Rating Inventory of Executive Function (BRIEF) T-score
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.
Measured: Baseline (at enrollment)
Total difficulties score assessed by Strengths and Difficulties Questionnaire (SDQ)
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.
Measured: Baseline (at enrollment)
Daily stress level assessed by Inventario de Estrés Cotidiano Infantil (IECI)
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.
Measured: Baseline (at enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start1 Nov 2020
- Primary completion30 Apr 2022
- Study completion22 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heathly Subjects Susceptible to SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 932 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Spanish National Research Council
- Sponsor type
- Other government
- Collaborators
- Interdisciplinary Thematic Platform (PTI+) Global Health (CSIC)
- Responsible party
- Principal investigator, Yolanda Sanz Herranz, Spanish National Research Council
- Investigators
- Yolanda Professor Sanz, Principal Investigator, Principal investigator, Instituto de Agroquímica y Tecnología de Alimentos (IATA-CSIC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07717008
- Sponsor's protocol ID
- PRE131/20
- Acronym
- PREDICOL
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Risk Predictors for SARS-CoV-2 Infection Based on the Microbiome of School-age Children and Their Family Members (PREDICOL)
- ClinicalTrials.gov ID
- NCT07717008
- Acronym / sponsor ID
- PREDICOL / PRE131/20
- Keywords
- Gut microbiota, Diet, SARS-CoV-2, Learning disorders, Metacognition, Behaviour
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 932 participants (actual)
- Lead sponsor
- Spanish National Research CouncilOther government
- Collaborators
- Interdisciplinary Thematic Platform (PTI+) Global Health (CSIC)
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 22 Dec 2024 (actual)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- History of confirmed SARS-CoV-2 infection, positive serology (IgM/IgG).
- NOT have any minors living with them in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relative abundance of intestinal microbial taxa associated with SARS-CoV-2 infection
Time frame: 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.
8 secondary outcomes
Learning difficulties assessed by DSM-5 criteria
Time frame: Baseline (at enrollment)
Dietary pattern adherence score derived from principal component analysis
Time frame: Baseline (at enrollment)
Compliance with age- and sex-specific dietary recommendations
Time frame: Baseline (at enrollment)
Daily food group intake assessed by EPIC Food Frequency Questionnaire (grams/day)
Time frame: Baseline (at enrollment)
Daily nutrient intake assessed by EPIC Food Frequency Questionnaire (grams/day)
Time frame: Baseline (at enrollment)
Executive function assessed by Behavior Rating Inventory of Executive Function (BRIEF) T-score
Time frame: Baseline (at enrollment)
Total difficulties score assessed by Strengths and Difficulties Questionnaire (SDQ)
Time frame: Baseline (at enrollment)
Daily stress level assessed by Inventario de Estrés Cotidiano Infantil (IECI)
Time frame: Baseline (at enrollment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yolanda Professor Sanz, Principal Investigator principal investigator
Instituto de Agroquímica y Tecnología de Alimentos (IATA-CSIC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heathly Subjects Susceptible to SARS-CoV-2 Infection, run by Spanish National Research Council at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative abundance of intestinal microbial taxa associated with SARS-CoV-2 infection (time frame: Baseline (at enrollment).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.