Evaluation of the Variation of the Intestinal Microbiota and the Integrity of the Intestinal Barrier in Patients With M.D.R. Germ-induced Pneumonia Undergoing Enteral Nutrition

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
at Baseline and after 10 days

Secondary outcomes

1

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

Time frame
at Baseline and after 10 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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: