Microbial ColonizationMicrobiotaNCT05854264
Influence of Nutrition on Lung Microbiota in Traumatic Brain Injury
A study testing standard enteral nutrition and specialized nutrition in people with Microbial Colonization, run by University of Foggia at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Microbial Colonization
- What is being tested?
- standard enteral nutrition and specialized nutrition
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2021to 1 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults (age > 18 years),
- paziente with traumatic brain injury
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Ospedali Riuniti
Foggia, Apulia, 71100
Antonella Cotoia, MD, +39 3297174175, antonella.cotoia@unifg.it
Gilda Cinnella, MD, gilda.cinnella@unifg.it
About this study
Official title: 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.
Read the 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
- Conditions
- Microbial Colonization
- Being tested
- standard enteral nutrition, specialized nutrition
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard enteral nutritionDietary supplement
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.
specialized nutritionDietary supplement
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 group | Role | What they receive |
|---|---|---|
| microbiota and specialized nutrition | Active comparator | microbiota analysis in lower lavage (Bronco Alveolar Lavage: BAL) samples in patietns treated with specialized nutrition Receives: Dietary Supplement: specialized nutrition |
| microbiota and standard nutrition | Sham comparator | microbiota analysis in lower lavage (Bronco Alveolar Lavage: BAL) samples in patients treated with standard nutrition Receives: Dietary Supplement: standard enteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
infection
pulmonary infection in mechanically ventilated patients
Measured: pulmonary infection within 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start1 Feb 2021
- Primary completion30 Apr 2023 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- specialized nutrition group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Foggia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cotoia Antonella, University of Foggia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854264
- Sponsor's protocol ID
- 46/CE/2022
- Acronym
- Microbiota
- Status last verified
- May 2023
- First submitted
- 22 Apr 2023
- Last updated
- 11 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Microbiota in Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT05854264
- Acronym / sponsor ID
- Microbiota / 46/CE/2022
- Conditions
- Microbial Colonization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of FoggiaUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- specialized nutrition group
| Arm | Type | Receives |
|---|---|---|
| microbiota and specialized nutrition | Active comparator | Dietary Supplement: specialized nutritionmicrobiota analysis in lower lavage (Bronco Alveolar Lavage: BAL) samples in patietns treated with specialized nutrition |
| microbiota and standard nutrition | Sham comparator | Dietary Supplement: standard enteral nutritionmicrobiota analysis in lower lavage (Bronco Alveolar Lavage: BAL) samples in patients treated with standard nutrition |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adults (age > 18 years),
- paziente with traumatic brain injury
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard enteral nutritionstandard 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 supplement | microbiota and standard nutrition |
| specialized nutritionspecialized 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 supplement | microbiota and specialized nutrition |
Primary outcome
infection
Time frame: pulmonary infection within 28 days
pulmonary infection in mechanically ventilated patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard enteral nutrition and specialized nutrition in people with Microbial Colonization, run by University of Foggia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonella Cotoia (+390881732387, antonella.cotoia@unifg.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
infection (time frame: pulmonary infection within 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.