Ignite Creation Date:
2024-07-17 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06485791
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-20
Brief Title:
Evaluation of the Variation of the Intestinal Microbiota and the Integrity of the Intestinal Barrier in Patients With MDR Germ-induced Pneumonia Undergoing Enteral Nutrition
Sponsor:
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Organization:
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Study Overview
Official Title:
Evaluation of the Variation of the Intestinal Microbiota and the Integrity of the Intestinal Barrier in Patients With MDR Germ-induced Pneumonia Undergoing Enteral Nutrition
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study aims to evaluate the effects of enteral nutrition in subjects with MDR on the intestinal microbiota
Detailed Description:
The MDR 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 13 million deathsyear
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 UOC 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 MDR germs
Once the overall clinical picture has stabilized ie the specialist needs have ceased patients come to the UOC 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 relativelegal 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 ie before starting artificial enteral nutrition and at V1 ie after 10 days of enteral nutritional administration
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 UOC 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 MDR germs
Once the overall clinical picture has stabilized ie the specialist needs have ceased patients come to the UOC 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 relativelegal 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 ie before starting artificial enteral nutrition and at V1 ie after 10 days of enteral nutritional administration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None