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

NCT06485791 | Not Yet Recruiting

• 1 other identifier: MDR&Microbiota
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study aims to evaluate the effects of enteral nutrition in subjects with MDR on the intestinal microbiota

Conditions

Multi Drug Resistant; Dysphagia

Keywords

Antibiotic resistance; Enteral nutrition

Outcome Measures

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.

  at Baseline and after 10 days

Secondary Outcomes (1)

• Evaluation of the integrity of the intestinal barrier

  at Baseline and after 10 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Patients admitted to the Intensive Care Unit suffering from lung infections caused by M.D.R. germs.

You may not qualify if:

• Patients hospitalized with other pathologies

Sponsors & Collaborators

• Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis: lead
• 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

Related Publications (3)

• Han Y, Zhang J, Zhang HZ, Zhang XY, Wang YM. Multidrug-resistant organisms in intensive care units and logistic analysis of risk factors. World J Clin Cases. 2022 Feb 26;10(6):1795-1805. doi: 10.12998/wjcc.v10.i6.1795.

  PMID: 35317164 BACKGROUND

• Kent AG, Vill AC, Shi Q, Satlin MJ, Brito IL. Widespread transfer of mobile antibiotic resistance genes within individual gut microbiomes revealed through bacterial Hi-C. Nat Commun. 2020 Sep 1;11(1):4379. doi: 10.1038/s41467-020-18164-7.

  PMID: 32873785 BACKGROUND

• Dubourg G, Lagier JC, Robert C, Armougom F, Hugon P, Metidji S, Dione N, Dangui NP, Pfleiderer A, Abrahao J, Musso D, Papazian L, Brouqui P, Bibi F, Yasir M, Vialettes B, Raoult D. Culturomics and pyrosequencing evidence of the reduction in gut microbiota diversity in patients with broad-spectrum antibiotics. Int J Antimicrob Agents. 2014 Aug;44(2):117-24. doi: 10.1016/j.ijantimicag.2014.04.020. Epub 2014 Jun 14.

  PMID: 25063078 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Feces, serum, urine.

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Nicola Cappellano, MD

  Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicola Cappellano, MD

CONTACT

0804994111; nicola.cappellano@irccsdebellis.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: July 3, 2024
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 3, 2024

Record last verified: 2024-06