Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05765994 |
Other study ID # |
207 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
November 19, 2018 |
Est. completion date |
July 8, 2019 |
Study information
Verified date |
March 2023 |
Source |
University of Ioannina |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
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 and/or 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 and/or 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; 1st/day 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.