Influence of Nutrition on Lung Microbiota in Traumatic Brain Injury
Microbiota
Lung Microbiota in Traumatic Brain Injury
1 other identifier
interventional
30
1 country
1
Brief Summary
Role of immunonutrition in modulating the lung microbiota of intubated TBJ patients and how this interaction may affect the infections and outcomes. For these reasons, the aims of our study are the evaluation of the impact of immunonutrition on the lung microbiota and the relationship between lung microbiota and infection in TBJ patients in ICU.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2021
CompletedFirst Submitted
Initial submission to the registry
April 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedFirst Posted
Study publicly available on registry
May 11, 2023
CompletedMay 11, 2023
May 1, 2023
2.2 years
April 22, 2023
May 10, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
infection
pulmonary infection in mechanically ventilated patients
pulmonary infection within 28 days
Study Arms (2)
microbiota and specialized nutrition
ACTIVE COMPARATORmicrobiota analysis in lower lavage (Bronco Alveolar Lavage: BAL) samples in patietns treated with specialized nutrition
microbiota and standard nutrition
SHAM COMPARATORmicrobiota analysis in lower lavage (Bronco Alveolar Lavage: BAL) samples in patients treated with standard nutrition
Interventions
standard enteral nutrition. The calories (25 kcal/kg/die) and protein (1.2 g/kg/die) target will be progressively reached in the first week of ICU stay.
specialized enteral nutrition. The calories (25 kcal/kg/die) and protein (1.2 g/kg/die) target will be progressively reached in the first week of ICU stay.
Eligibility Criteria
You may qualify if:
- adults (age \> 18 years),
- paziente with traumatic brain injury
You may not qualify if:
- pregnant women,
- patients with gastric content inhalation
- patients with chronic inflammatory bowel diseases
- patients underwent major abdominal surgery and/or organs/tissues transplant
- patients on corticosteroid and/or immunosuppressive therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ospedali Riuniti
Foggia, Apulia, 71100, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- specialized nutrition and microbiota analysis
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 22, 2023
First Posted
May 11, 2023
Study Start
February 1, 2021
Primary Completion
April 30, 2023
Study Completion
May 1, 2023
Last Updated
May 11, 2023
Record last verified: 2023-05