Influence of Nutrition on Lung Microbiota in Traumatic Brain Injury

Lung Microbiota in Traumatic Brain Injury

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05854264

Acronym

Microbiota

Enrollment

Registered

2023-05-11

Start date

2021-02-01

Completion date

2023-05-01

Last updated

2023-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microbial Colonization

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

Interventions

DIETARY_SUPPLEMENTstandard 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.

DIETARY_SUPPLEMENTspecialized 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Masking description

specialized nutrition and microbiota analysis

Intervention model description

specialized nutrition group

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
infection	pulmonary infection within 28 days	pulmonary infection in mechanically ventilated patients

Countries

Italy

Contacts

Primary ContactAntonella Cotoia

antonella.cotoia@unifg.it+390881732387

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026