Multi Drug ResistantNCT06485791
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 of Multi Drug Resistant and Dysphagia, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis.
Trial summary
The study aims to evaluate the effects of enteral nutrition in subjects with MDR on the intestinal microbiota Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multi Drug Resistant, Dysphagia
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 1 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients admitted to the Intensive Care Unit suffering from lung infections caused by M.D.R. germs.
Who cannot join
- Patients hospitalized with other pathologies
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Multi Drug Resistant, Dysphagia
- Keywords
- Antibiotic resistance, Enteral nutrition
- Medical subject headings
- Deglutition Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: at Baseline and after 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multi Drug ResistantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Dr. Nicola Cappellano - MD, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Investigators
- Nicola Cappellano, MD, Principal investigator, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485791
- Sponsor's protocol ID
- MDR&Microbiota
- Status last verified
- Jun 2024
- First submitted
- 20 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 35317164Kent 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 32873785Dubourg 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06485791
- Acronym / sponsor ID
- MDR&Microbiota
- Conditions
- Multi Drug Resistant, Dysphagia
- Keywords
- Antibiotic resistance, Enteral nutrition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de BellisUniversity, hospital or other
- 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
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to evaluate the effects of enteral nutrition in subjects with MDR on the intestinal microbiota
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients admitted to the Intensive Care Unit suffering from lung infections caused by M.D.R. germs.
Key exclusion criteria (1 listed)
- Patients hospitalized with other pathologies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composition of the microbiota
Time frame: at Baseline and after 10 days
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.
1 secondary outcome
Evaluation of the integrity of the intestinal barrier
Time frame: at Baseline and after 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Background: PubMed 35317164Han 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.
- Background: PubMed 32873785Kent 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.
- Background: PubMed 25063078Dubourg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicola Cappellano, MD principal investigator
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Questions about this trial
What is this clinical trial studying?
An observational study of Multi Drug Resistant and Dysphagia, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicola Cappellano, MD (0804994111, nicola.cappellano@irccsdebellis.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composition of the microbiota (time frame: at Baseline and after 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06485791, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.