Critical IllnessBIOUCIPNCT04435470
Epidemiological Study of the Microbiota in Critically Ill Children
An observational study of Critical Illness and Child, Only, run by Universidad de Granada at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 month to 16 years
- Conditions the study is for
- Critical Illness, Child, Only, Intensive Care Unit
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2020to 31 Jul 2023
- 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 1 month to 16 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- admission to pediatric intensive care unit
- hospitalization time expectancy more than 5 days
- age between 1 month and 16 years
- informed consent signed
Who cannot join
- hospitalization time expectancy less than 5 days
- no signed informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Critical Illness, Child, Only, Intensive Care Unit
- Keywords
- microbiota, inflammation, metabolomic
- Medical subject headings
- Critical Illness, Inflammation
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 |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
To identify intestinal and respiratory microbiota and if their changes are related with digestive and infectious complications
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.
Measured: At admission and through study completion, at least 5 days
Secondary outcomes (10)
To compare intestinal and respiratory microbiota of critically ill children with a cohort of healthy children
To compare intestinal and respiratory microbiota of critically ill children when admitted to the pediatric intensive care unit with a cohort of healthy children
Measured: 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
To study the clinical factors and influencing the changes in the intestinal microbiota during admission to the pediatric intensive care unit
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: At admission and through study completion, at least 5 days
To analyse the relationship between changes in microbiota and inflammatory biomarkers
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
Measured: 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
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
Measured: At admission and through study completion, at least 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start1 Jun 2020
- Primary completion28 Feb 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Materno-Infantil Torrecárdenas de Almería, Hospital Materno-Infantil de Málaga, Complejo Hospitalario Universitario de Santiago, University Hospital Virgen de las Nieves
- Responsible party
- Principal investigator, María Dolores Mesa García, Universidad de Granada
- Investigators
- MARÍA DOLORES MESA GARCÍA, PhD, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04435470
- Sponsor's protocol ID
- BIOUCIP
- Other IDs
- PI18/01334
- Acronym
- BIOUCIP
- Status last verified
- Mar 2025
- First submitted
- 11 Jun 2020
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study Protocol
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study of the Microbiota in Critically Ill Children and Its Relationship With Clinical Complications and Inflammation Biomarkers
- ClinicalTrials.gov ID
- NCT04435470
- Acronym / sponsor ID
- BIOUCIP / BIOUCIP
- Conditions
- Critical Illness, Child, Only, Intensive Care Unit
- Keywords
- microbiota, inflammation, metabolomic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Collaborators
- Hospital Materno-Infantil Torrecárdenas de Almería, Hospital Materno-Infantil de Málaga, Complejo Hospitalario Universitario de Santiago, University Hospital Virgen de las Nieves
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 17 Jun 2020 (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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Critical ill children | – | –Critial ill children admited in pediatric intensive care units 1-16 years old |
| Control | – | –Healthy children 1-16 years old |
Who may qualify
- Ages
- 1 month to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (4 listed)
- admission to pediatric intensive care unit
- hospitalization time expectancy more than 5 days
- age between 1 month and 16 years
- informed consent signed
Key exclusion criteria (2 listed)
- hospitalization time expectancy less than 5 days
- no signed informed consent
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
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.
10 secondary outcomes
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 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 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 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 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 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 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 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 changes in microbiota and inflammatory biomarkers
Time frame: 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
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 1 Apr 2025.
- Individual participant dataSharing planned: No. Study Protocol
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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.
MARÍA DOLORES MESA GARCÍA, PhD principal investigator
Universidad de Granada
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 Critical Illness and Child, Only, run by Universidad de Granada 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 4 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 1 Apr 2025. 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?
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). 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 1 Apr 2025.