An interventional study of standard enteral nutrition and specialized nutrition in Microbial Colonization, sponsored by University of Foggia. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-05-11.
Sponsored by University of Foggia · Not applicable, Interventional, and Diagnostic
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.
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
626 studies on the registry are indexed under Communicable Diseases; 128 are open to participants now.
This study's planned enrollment of 30 is below the median of 89 across 380 interventional studies indexed under Communicable Diseases.
Browse Communicable Diseases studies →University of Foggia is the lead sponsor of 36 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
microbiota analysis in lower lavage (Bronco Alveolar Lavage: BAL) samples in patietns treated with specialized nutrition
Dietary Supplement: specialized 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.
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.
infection
pulmonary infection in mechanically ventilated patients
Time frame: pulmonary infection within 28 days
Started Feb 2021 (actual). Primary completion is estimated for Apr 2023, 26 months after the start.
Of 128 non-industry interventional studies with no phase under Communicable Diseases, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's planned 26 months is above that.
Counting every sponsor, half of 144 studies reached it within 21 months; a quarter within 6 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
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University of Foggia