About this trial
The study aims to evaluate the effects of enteral nutrition in subjects with MDR on the intestinal microbiota
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients admitted to the Intensive Care Unit suffering from lung infections caused by M.D.R. germs.
Disqualifiers
Patients hospitalized with other pathologies
Trial population
This study will enroll patients who will be hospitalized in the U.O.C. of Anesthesia and Intensive Care of our institution, after having been admitted to other hospitals following a traumatic event which required mechanical ventilation. Following tracheostomy, patients developed an infection. The infection was subsequently treated with high doses of various antibiotics which led to the onset of pneumonia caused by M.D.R. germs. Once the overall clinical picture has stabilized, i.e. the specialist needs have ceased, patients come to the U.O.C. of Anesthesia and Intensive Care Unit with a clinical picture compromised by the use of antibiotics, which caused a modification of the intestinal bacterial flora and microbiota. Therefore they are hospitalized to proceed with nutritional rehabilitation using Enteral Nutrition, as they are very often dysphagic and therefore unable to feed themselves independently, and consequently "wash out" of antibiotics from the moment of transfer.
Trial design
Case-only
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Composition of the microbiota
Improvement in the composition of the intestinal microbiota. Characterization of the microbiome will be carried out using a DNA metabarcoding and shotgun metatranscriptomics approach. DNA metabarcoding analysis will be conducted using the V5-V6 hypervariable regions of 16S rRNA for bacteria (MiSeq-Illumina platform). Samples found significant at DNA metabarcoding analysis will be subjected to metatracriptomic analysis (NextSeq 500 platform-Illumina). Metagenomic and metatracriptomic data will be analyzed using bioinformatics pipelines.
Secondary outcomes
Evaluation of the integrity of the intestinal barrier
Improved intestinal barrier function and integrity, assessed by measuring fecal zonulin and indole and skatole by elisa technique
Locations
Sponsors and contacts
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Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Lead sponsor
Russo Francesco, MD
Collaborator
Rossella Donghia, Biologist
Collaborator
Maria Notarnicola, Clinical Pathology Director
Collaborator
Pasqua Letizia Pesole, Biologist
Collaborator
Sergio Coletta, Laboratory Technician
Collaborator
Anna Ancora, Laboratory Technician
Collaborator
Francesco Gabriele, Intensive Care Unit Director
Collaborator
This trial is not recruiting at the moment. You can still explore other options: