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Not yet recruitingNCT06485791Updated Jul 3, 2024

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

An observational study in Multi Drug Resistant and Dysphagia, sponsored by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-03.

Sponsored by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 3 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
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Study summary

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

Read the detailed description

The M.D.R. it is defined as multiple resistance to antibiotics and its prevalence in intensive care units (ICU) is continuously increasing throughout the world, with great variability between continents, but also between the microorganisms themselves involved. It is estimated that global mortality attributable to antibiotic resistance is approximately 1.3 million deaths/year.

The study in question is a prospective observational study in which the effect of enteral nutrition in patients suffering from MDR on the intestinal microbiota will be evaluated. This study will enroll patients who will be hospitalized at the Resuscitation Center in the U.O.C. of Anesthesia and Resuscitation 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 detected by tracheobronchial aspirate 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. In fact, these patients present soft or liquid stools, as well as persistent diarrhea. 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.

As per normal clinical practice, enteral nutrition is started for these patients to avoid the risk of malnutrition. For the purpose of standardizing the study, three different commercial formulations of enteral nutrition are used depending on the presence or absence of concomitant pathologies:

  • Jevity Plus from the Abbot company for patients who do not have prevalent pathologies;
  • Oxepa from the Abbot company for patients presenting with acute pneumonia;
  • Novasource Gi Balance from the Nestlé company for diabetic patients in whom glycemic control is necessary due to diabetes mellitus.

Treatment with enteral nutrition lasts 10 days, at the end of which patients are discharged or, alternatively, leave the study.

For this study, the investigators will collect stool, urine, and serum samples for analysis of the fecal microbiota and metabolome and assessment of intestinal barrier integrity.

After signing the informed consent by the patient or by a close relative/legal representative (in the hypothesis that the patient is incapable of signing the consent), the investigator will proceed with the collection of the samples.

The samples will be collected at V0 upon admission, i.e. before starting artificial enteral nutrition, and at V1, i.e. after 10 days of enteral nutritional administration.

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Conditions studied

  • Multi Drug Resistant
  • Dysphagia

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Keywords

  • Antibiotic resistance
  • Enteral nutrition
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In context

Pneumonia

2,045 studies on the registry are indexed under Pneumonia; 284 are open to participants now.

This study's planned enrollment of 50 is below the median of 201 across 689 observational studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis is the lead sponsor of 54 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients hospitalized with other pathologies
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

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

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 35317164 ↗
  • 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. PubMed 32873785 ↗
  • 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. PubMed 25063078 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06485791
Lead sponsor
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Collaborators
Russo Francesco, MD, Rossella Donghia, Biologist, Maria Notarnicola, Clinical Pathology Director, Pasqua Letizia Pesole, Biologist, Sergio Coletta, Laboratory Technician, Anna Ancora, Laboratory Technician, Francesco Gabriele, Intensive Care Unit Director
Responsible party
Dr. Nicola Cappellano - MD (Principal Investigator, MD, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis) — Principal investigator
First posted
Jul 3, 2024
Start date
Jul 1, 2024 (estimated)
Primary completion
Jul 1, 2025 (estimated)
Completion
Jul 1, 2026 (estimated)
Last update
Jul 3, 2024

Study contacts

Nicola Cappellano, MD
Contact
nicola.cappellano@irccsdebellis.it
0804994111
Nicola Cappellano, MD
principal investigator · Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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