Influence of Nutrition on Lung Microbiota in Traumatic Brain Injury

Microbial Colonization Clinical Trial

— Microbiota  

Official title:

Lung Microbiota in Traumatic Brain Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05854264
• Other study ID #: 46/CE/2022
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: May 1, 2023

Study information

• Verified date: May 2023
• Source: University of Foggia
• Contact: Antonella Cotoia
• Phone: +390881732387
• Email: antonella.cotoia[@]unifg.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 1, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Communicable Diseases
• Infections
• Microbial Colonization

Intervention

Dietary Supplement:
• standard enteral nutrition
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 nutrition
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.

Locations

Country	Name	City	State
Italy	Ospedali Riuniti	Foggia	Puglia

Sponsors (1)

Lead Sponsor	Collaborator
University of Foggia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	infection	pulmonary infection in mechanically ventilated patients	pulmonary infection within 28 days