Influence of Nutrition on Lung Microbiota in Traumatic Brain Injury

Sponsor

University of Foggia (Other)

Overall Status

Recruiting

CT.gov ID

NCT05854264

Collaborator

(none)

Enrollment

Location

Arms

26.9

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Microbial Colonization	Dietary Supplement: standard enteral nutrition Dietary Supplement: specialized nutrition	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

specialized nutrition groupspecialized nutrition group

Masking:

Single (Participant)

Masking Description:

specialized nutrition and microbiota analysis

Primary Purpose:

Diagnostic

Official Title:

Lung Microbiota in Traumatic Brain Injury

Actual Study Start Date :

Feb 1, 2021

Anticipated Primary Completion Date :

Apr 30, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: microbiota and specialized nutrition microbiota analysis in lower lavage (Bronco Alveolar Lavage: BAL) samples in patietns treated with specialized nutrition	Dietary Supplement: 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.
Sham Comparator: microbiota and standard nutrition microbiota analysis in lower lavage (Bronco Alveolar Lavage: BAL) samples in patients treated with standard nutrition	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.

Arm

Intervention/Treatment

Active Comparator: microbiota and specialized nutrition

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

Dietary Supplement: 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.

Sham Comparator: microbiota and standard nutrition

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

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.

Outcome Measures

Primary Outcome Measures

infection [pulmonary infection within 28 days]
pulmonary infection in mechanically ventilated patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ospedali Riuniti	Foggia	Puglia	Italy	71100

Sponsors and Collaborators

University of Foggia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cotoia Antonella, Principal Investigator, University of Foggia

ClinicalTrials.gov Identifier:

NCT05854264

Other Study ID Numbers:

46/CE/2022

First Posted:

May 11, 2023

Last Update Posted:

May 11, 2023

Last Verified:

May 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Communicable Diseases

Infections

Brain Injuries

Brain Injuries, Traumatic

Study Results

No Results Posted as of May 11, 2023