Back to resultsInfluence of Nutrition on Lung Microbiota in Traumatic Brain Injury (Microbiota)
Primary Purpose
Microbial Colonization
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
standard enteral nutrition
specialized nutrition
Sponsored by
About this trial
This is an interventional diagnostic trial for Microbial Colonization
Eligibility Criteria
Inclusion Criteria: adults (age > 18 years), paziente with traumatic brain injury Exclusion Criteria: 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
Sites / Locations
- Ospedali RiunitiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
microbiota and specialized nutrition
microbiota and standard nutrition
Arm Description
microbiota analysis in lower lavage (Bronco Alveolar Lavage: BAL) samples in patietns treated with specialized nutrition
microbiota analysis in lower lavage (Bronco Alveolar Lavage: BAL) samples in patients treated with standard nutrition
Outcomes
Primary Outcome Measures
infection
pulmonary infection in mechanically ventilated patients
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05854264
Brief Title
Influence of Nutrition on Lung Microbiota in Traumatic Brain Injury
Acronym
Microbiota
Official Title
Lung Microbiota in Traumatic Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
May 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Foggia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
Detailed Description
Traumatic brain injury patients, requiring mechanical ventilation admitted to ICU will be randomly divide in two groups receiving standard nutrition or specialized formula.
Lower lavage (Bronco Alveolar Lavage: BAL) samples will be collected at admission in ICU and at day 7 for the microbiota analysis. Clinical follow-up at day 28 will be obtained
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microbial Colonization
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
specialized nutrition group
Masking
Participant
Masking Description
specialized nutrition and microbiota analysis
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
microbiota and specialized nutrition
Arm Type
Active Comparator
Arm Description
microbiota analysis in lower lavage (Bronco Alveolar Lavage: BAL) samples in patietns treated with specialized nutrition
Arm Title
microbiota and standard nutrition
Arm Type
Sham Comparator
Arm Description
microbiota analysis in lower lavage (Bronco Alveolar Lavage: BAL) samples in patients treated with standard nutrition
Intervention Type
Dietary Supplement
Intervention Name(s)
standard enteral nutrition
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
specialized nutrition
Intervention Description
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.
Primary Outcome Measure Information:
Title
infection
Description
pulmonary infection in mechanically ventilated patients
Time Frame
pulmonary infection within 28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adults (age > 18 years),
paziente with traumatic brain injury
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonella Cotoia
Phone
+390881732387
Email
antonella.cotoia@unifg.it
Facility Information:
Facility Name
Ospedali Riuniti
City
Foggia
State/Province
Puglia
ZIP/Postal Code
71100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonella Cotoia, MD
Phone
+39 3297174175
Email
antonella.cotoia@unifg.it
First Name & Middle Initial & Last Name & Degree
Gilda Cinnella, MD
Email
gilda.cinnella@unifg.it
12. IPD Sharing Statement
Learn more about this trial
Influence of Nutrition on Lung Microbiota in Traumatic Brain Injury
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