Epidemiological Study of the Microbiota in Critically Ill Children (BIOUCIP)

March 31, 2025 updated by: María Dolores Mesa García, Universidad de Granada

Epidemiological Study of the Microbiota in Critically Ill Children and Its Relationship With Clinical Complications and Inflammation Biomarkers

Objectives: To study the composition of the microbiota in critically ill children, and to know the relationship of its microbiota with clinical complications and inflammation biomarkers.

Design: Multicenter observational and prospective study including 100 critically ill children admitted in three pediatric intensive care units with a prediction of more than 5 days of stay and 50 healthy children. Clinical parameters and rectal, fecal, blood and respiratory samples will be collected at admission and at pediatric intensive care units discharge. The microbiota and inflammation biomarkers and metabolomic will be analyzed.

Analysis of results: Description an evolution of the microbiota throughout the time, intestinal and respiratory, and the influence of clinical and therapeutic factors will be analyzed. The composition of microbiota will be compared with a cohort of healthy children and between the different types of pediatric intensive care units. The correlation of the microbiota with the markers of inflammation, metabolomics and the development of infectious complications and multiorgan failure will be analyzed.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

AIM: The present study is an observational clinical study aimed to study the intestinal microbiota composition of critically ill children in paediatric intensive care unit and its relationship with clinical complications and inflammatory biomarkers.

DESIGN: This study is a multicentre, observational and prospective study including 100 critically ill children admitted in three paediatric intensive care units (Hospital Materno-Infantil Torrecárdenas de Almería, y en el Hospital Materno-Infantil Carlos Haya de Málaga and Complejo Hospitalario Universitario de Santiago) This study is a multicentre, observational and prospective study conducted by members of the Department of Biochemistry and Molecular Biology II, Nutrition and Food Technology Institute "José Mataix" of the University of Granada research group in collaboration with the Hospital Materno-Infantil Torrecárdenas from Almería, the Hospital Materno-Infantil Carlos Haya from Málaga and Complejo Hospitalario Universitario from Santiago de Compostela pediatric intensive care units and primary care unit of the University Hospital Virgen de las Nieves from Granada as recruitment centres.

This trial will include 100 critically ill children admitted from the three different pediatric intensive care units with an expected hospitalization time of more than 5 days. In addition, 50 healthy children will be recruited from a primary care centre as controls. Faecal and respiratory system (oropharynx) samples will be collected from ill and healthy children, while blood samples will be harvested only from critically ill children at the time of admission to the pediatric intensive care units as well as at the day of discharge. Sample aliquots will be sent to the Department of Biochemistry and Molecular Biology II, University of Granada for further analysis.

Study population The study population will comprise 50 healthy children aged between 1 month and 16 years, recruited in a paediatric primary care center from Granada, and 100 critically ill children admitted to the pediatric intensive care units aged between 1 month and 16 years. 50 patients will be recruited at the pediatric intensive care units of Hospital Materno-Infantil Torrecárdenas from Almería, the Hospital Materno-Infantil Carlos Haya from Málaga and Complejo Hospitalario Universitario from Santiago de Compostela. Only those children who satisfy all inclusion and none of exclusion criteria will be included in the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: MARÍA DOLORES MESA GARCÍA, PhD
  • Phone Number: 958246187
  • Email: mdmesa@ugr.es

Study Contact Backup

  • Name: JOSE MALDONADO, PhD
  • Phone Number: 958242334
  • Email: jmaldon@ugr.es

Study Locations

  • Spain
    • Granada
      • Armilla, Granada, Spain, 18071
        • María Dolores Mesa García

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 12 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Critical ill children admited to pediatric intensive care unit, with a hospitalization time expectancy more than 5 days Control subjects will be healthy children

Description

Inclusion Criteria:

  • admission to pediatric intensive care unit
  • hospitalization time expectancy more than 5 days
  • age between 1 month and 16 years
  • informed consent signed

Exclusion Criteria:

  • hospitalization time expectancy less than 5 days
  • no signed informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Critical ill children
Critial ill children admited in pediatric intensive care units 1-16 years old
Control
Healthy children 1-16 years old

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To identify intestinal and respiratory microbiota and if their changes are related with digestive and infectious complications
Time Frame: At admission and through study completion, at least 5 days
To analyse the intestinal and respiratory microbiota in critically ill children admitted to the pediatric intensive care unit through massive sequencing, and evaluate if their changes are related with the appearance of digestive and infectious complications and the development of multiorgan failure.
At admission and through study completion, at least 5 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To compare intestinal and respiratory microbiota of critically ill children with a cohort of healthy children
Time Frame: Samples will be taken at admission to pediatric intensive care unit and a single sample witl be taken from healthy controls
To compare intestinal and respiratory microbiota of critically ill children when admitted to the pediatric intensive care unit with a cohort of healthy children
Samples will be taken at admission to pediatric intensive care unit and a single sample witl be taken from healthy controls
To study the clinical factors influencing the changes in the intestinal microbiota during admission to the pediatric intensive care unit
Time Frame: At admission and through study completion, at least 5 days
To study the clinical factors and influencing the changes in the intestinal microbiota during admission to the pediatric intensive care unit
At admission and through study completion, at least 5 days
To compare the changes of the microbiota according to the type of critical patients and the type of pediatric intensive care unit
Time Frame: At admission and through study completion, at least 5 days
To compare the changes in the composition of intestinal and respiratory microbiota according to the type of critical patients and the type of pediatric intensive care unit
At admission and through study completion, at least 5 days
To assess the relationship between changes in the intestinal microbiota and the frequency and severity of digestive complications
Time Frame: At admission and through study completion, at least 5 days
To assess the relationship between the composition of the intestinal microbiota and the frequency and severity of digestive complications (diarrhea, constipation and tolerance of enteral nutrition) in critical ill children admitted to the pediatric intensive care unit
At admission and through study completion, at least 5 days
To study the relationship between changes in the intestinal and respiratory microbiota and the frequency and severity of nosocomial infection
Time Frame: At admission and through study completion, at least 5 days
To study the relationship between the composition of intestinal and respiratory microbiota and the frequency and severity of nosocomial infection in critically ill children admitted to the pediatric intensive care unit
At admission and through study completion, at least 5 days
To study the relationship between changes in the intestinal and respiratory microbiota and the development of multiorgan failure
Time Frame: At admission and through study completion, at least 5 days
To study the relationship between the intestinal and respiratory microbiota and the development of multiorgan failure in critical ill children admitted to the pediatric intensive care unit
At admission and through study completion, at least 5 days
To determine changes in the serum levels of lipopolysaccharide and lipopolysaccharide binding protein and to evaluate their relationship with intestinal and respiratory microbiota
Time Frame: At admission and through study completion, at least 5 days
To determine the serum levels of lipopolysaccharide (LPS) and lipopolysacchaide binding protein (LPB) in critical ill children admitted to the pediatric intensive care unit, and to evaluate their relationship with intestinal and respiratory microbiota, the evolution during admission and the relationship with clinical complications
At admission and through study completion, at least 5 days
To analyse the relationship between changes in the intestinal and respiratory microbiota plasma sort chain fatty acids and bile acids
Time Frame: At admission and through study completion, at least 5 days
To analyse the relationship between the intestinal and respiratory microbiota and the metabolomic profile, especially short chain fatty acids (SCFA) and bile acids, in critical ill children admitted to the pediatric intensive care unit, the evolution during admission and the relationship with clinical complications
At admission and through study completion, at least 5 days
To analyse the relationship between changes in microbiota and inflammatory biomarkers
Time Frame: At admission and through study completion, at least 5 days
To analyse the relationship between microbiota and inflammatory biomarkers in critical ill children admitted to the pediatric intensive care unit, the evolution during admission and the relationship with clinical complications
At admission and through study completion, at least 5 days
To assess the influence of the type of nutrition during admission and changes of intestinal microbiota
Time Frame: At admission and through study completion, at least 5 days
To assess whether the type of nutrition, enteral or parenteral, of critical ill children during admision to pediatric intensive care unit and to evaluate their influences with the composition of the intestinal microbiota, and the relationship with clinical complications
At admission and through study completion, at least 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad de Granada

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Complejo Hospitalario Universitario de Santiago
University Hospital Virgen de las Nieves
Hospital Materno-Infantil de Málaga
Hospital Materno-Infantil Torrecárdenas de Almería

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: MARÍA DOLORES MESA GARCÍA, PhD, Universidad de Granada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 11, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BIOUCIP
  • PI18/01334 (Other Grant/Funding Number: Proyectos de Investigación en Salud ISCIII Spain)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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