Influence of Nutrition on Lung Microbiota in Traumatic Brain Injury

University of Foggia

Status: Enrolling

Conditions: Microbial Colonization

Treatments: Dietary Supplement: specialized nutrition; Dietary Supplement: standard enteral nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT05854264

46/CE/2022

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

microbiota and specialized nutrition

Active Comparator group

Description:

microbiota analysis in lower lavage (Bronco Alveolar Lavage: BAL) samples in patietns treated with specialized nutrition

Treatment:

Dietary Supplement: specialized nutrition

microbiota and standard nutrition

Sham Comparator group

Description:

microbiota analysis in lower lavage (Bronco Alveolar Lavage: BAL) samples in patients treated with standard nutrition

Treatment:

Dietary Supplement: standard enteral nutrition