Ignite Creation Date:
2024-05-06 @ 6:43 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05765994
Status:
COMPLETED
Last Update Posted:
2023-03-13
First Post:
2023-02-25
Brief Title:
Small Intestinal Bacterial Overgrowth in Critically Ill Patients
Sponsor:
University of Ioannina
Organization:
University of Ioannina
Study Overview
Official Title:
The Effects of Small Intestinal Bacterial Overgrowth Syndrome in ICU Patients An Observational Study
Status:
COMPLETED
Status Verified Date:
2023-03
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:
Small intestinal bacterial overgrowth SIBO syndrome though associated with potentially serious complications has not been adequately studied to date in critically ill patients hospitalized in intensive care units ICU
A modified method for SIBO diagnosis is employed concerning a standard breath test Specifically as all participants are intubated and in need of mechanical ventilation SIBO diagnosis is based on a non-invasive modified technique for sampling exhaled air from the ventilator tubes and performing a standard hydrogen breath test
The primary objective of this study is assessment of the prevalence of SIBO on ICU patients Secondary outcomes include investigation of the effects of SIBO on ventilator associated pneumonia as well as ICU length of stay and all-cause in-hospital mortality rate in critically ill patients
A modified method for SIBO diagnosis is employed concerning a standard breath test Specifically as all participants are intubated and in need of mechanical ventilation SIBO diagnosis is based on a non-invasive modified technique for sampling exhaled air from the ventilator tubes and performing a standard hydrogen breath test
The primary objective of this study is assessment of the prevalence of SIBO on ICU patients Secondary outcomes include investigation of the effects of SIBO on ventilator associated pneumonia as well as ICU length of stay and all-cause in-hospital mortality rate in critically ill patients
Detailed Description:
Small intestine bacterial overgrowth SIBO remains to this day a syndrome that is not fully understood Initially it was considered quite rare but today there are reports suggesting a SIBO prevalence between 6 to 15 of healthy asymptomatic people and reaching 80 in patients with irritable bowel syndrome It is often involved in various disorders such as diarrhea and malabsorption It is defined as an increase in the number andor disturbance in the type of bacteria in the upper part of the intestinal tract
SIBO occurs when the homeostatic mechanisms of the small intestine are disturbed The two main conditions that favor microbial overgrowth in the small intestine are decreased acid secretion from the stomach and small bowel dyskinesia
The literature is scarce concerning the effects of SIBO on critically ill patients To our knowledge this is the first study investigating the effects of SIBO on mechanically ventilated patients It is a non-invasive observational study employing a modified technique to obtain exhaled air from the ventilator tubes to perform a standard hydrogen breath test for SIBO diagnosis Lactulose is used as a substrate Specifically each patient is administered 20 g of lactulose diluted in 400 ml of water through the nasogastric tube Measurements are performed at 0-15-30-45-60-90-120-180 min from lactulose administration During measurements a valve attached to a collecting bag at the end of the expiratory limb of the breathing circuit is kept open and the collecting bag is filled by several patient exhalations After valve closure and bag isolation the air is drawn by a 50 ml polyethylene syringe which is connected to the valve system to prevent losses andor contamination Then the air is blown into the breath hydrogen monitor and the expired hydrogen measurement is recorded
The hydrogen breath test is repeated at predetermined protocol-based time intervals for all participants included in the study 1stday of admission 3rd 5th and 7th day of ICU stay The 1st day measurement serves as a measure of eligibility and patients exhibiting abnormal values of hydrogen breath testing at Day 1 are excluded from the study
An increase by more than 20 ppm of eH2 from baseline within 90 min was considered an abnormal measurement suggesting SIBO Moreover an increase by more than 12 ppm of eH2 from baseline within the first 30 minutes followed by a second rise within the next 15 minutes double peak was also considered an abnormal measurement suggesting SIBO
The primary objective of this study is assessment of the prevalence of SIBO on critically ill mechanically ventilated ICU patients Secondary outcomes include investigation of the effects of SIBO on ventilator associated pneumonia as well as ICU length of stay and all-cause in-hospital mortality rate in critically ill patients
SIBO occurs when the homeostatic mechanisms of the small intestine are disturbed The two main conditions that favor microbial overgrowth in the small intestine are decreased acid secretion from the stomach and small bowel dyskinesia
The literature is scarce concerning the effects of SIBO on critically ill patients To our knowledge this is the first study investigating the effects of SIBO on mechanically ventilated patients It is a non-invasive observational study employing a modified technique to obtain exhaled air from the ventilator tubes to perform a standard hydrogen breath test for SIBO diagnosis Lactulose is used as a substrate Specifically each patient is administered 20 g of lactulose diluted in 400 ml of water through the nasogastric tube Measurements are performed at 0-15-30-45-60-90-120-180 min from lactulose administration During measurements a valve attached to a collecting bag at the end of the expiratory limb of the breathing circuit is kept open and the collecting bag is filled by several patient exhalations After valve closure and bag isolation the air is drawn by a 50 ml polyethylene syringe which is connected to the valve system to prevent losses andor contamination Then the air is blown into the breath hydrogen monitor and the expired hydrogen measurement is recorded
The hydrogen breath test is repeated at predetermined protocol-based time intervals for all participants included in the study 1stday of admission 3rd 5th and 7th day of ICU stay The 1st day measurement serves as a measure of eligibility and patients exhibiting abnormal values of hydrogen breath testing at Day 1 are excluded from the study
An increase by more than 20 ppm of eH2 from baseline within 90 min was considered an abnormal measurement suggesting SIBO Moreover an increase by more than 12 ppm of eH2 from baseline within the first 30 minutes followed by a second rise within the next 15 minutes double peak was also considered an abnormal measurement suggesting SIBO
The primary objective of this study is assessment of the prevalence of SIBO on critically ill mechanically ventilated ICU patients Secondary outcomes include investigation of the effects of SIBO on ventilator associated pneumonia as well as ICU length of stay and all-cause in-hospital mortality rate in critically ill patients
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