Influence of Nutrition on Lung Microbiota in Traumatic Brain Injury (Microbiota)

May 10, 2023 updated by: Cotoia Antonella, University of Foggia

Lung Microbiota in Traumatic Brain Injury

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
infection
Time Frame: pulmonary infection within 28 days
pulmonary infection in mechanically ventilated patients
pulmonary infection within 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Foggia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Anticipated)

April 30, 2023

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

April 22, 2023

First Submitted That Met QC Criteria

May 10, 2023

First Posted (Estimate)

May 11, 2023

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 46/CE/2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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