Influence of Nutrition on Lung Microbiota in Traumatic Brain Injury

Not Applicable

Recruiting

• Conditions: Microbial Colonization
• Interventions: Dietary Supplement: standard enteral nutrition; Dietary Supplement: specialized nutrition

• Registration Number: NCT05854264
• Lead Sponsor: University of Foggia

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

Study Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2023-04-22
• Primary Completion: 2023-04-30
• Status Verified: 2023-05
• Study Completion: 2023-05-01
• Study First Submitted QC: 2023-05-10
• Last Update Submitted: 2023-05-10
• Study First Posted: 2023-05-11
• Last Update Posted: 2023-05-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
microbiota and standard nutrition	standard enteral nutrition	microbiota analysis in lower lavage (Bronco Alveolar Lavage: BAL) samples in patients treated with standard nutrition
microbiota and specialized nutrition	specialized nutrition	microbiota analysis in lower lavage (Bronco Alveolar Lavage: BAL) samples in patietns treated with specialized nutrition

Primary Outcome Measures

Name	Time	Method
infection	pulmonary infection within 28 days	pulmonary infection in mechanically ventilated patients

Trial Locations

Locations (1)

Ospedali Riuniti; 🇮🇹 Foggia, Puglia, Italy