Small Intestinal Bacterial OvergrowthNCT05765994
Small Intestinal Bacterial Overgrowth in Critically Ill Patients
An observational study of Small Intestinal Bacterial Overgrowth and Critical Illness, run by University of Ioannina at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Intestinal Bacterial Overgrowth, Critical Illness, Intensive Care Unit
- What is being tested?
- Modified hydrogen breath test
- How many people
- 52 participants
- Where
- 1 siteGreece
- Study dates
- 19 Nov 2018to 8 Jul 2019
- 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: Adult critically ill patients admitted to the ICU and in need of mechanical ventilation.
Who may be able to join
- critically ill patients, in need of mechanical ventilation with an expected ICU length of stay and expected mechanical ventilation duration of more than 48 hours
Who cannot join
- abnormal hydrogen breath test on the day of ICU admission (Day 1)
- recent (up to four weeks before ICU admission) antimicrobial therapy or patients already receiving antimicrobial therapy on admission
- recent (up to four weeks before ICU admission) use of gastroprotective medication, probiotics and prokinetics
- patients with known gastrointestinal disease prior to admission
- recent abdominal surgery resulting in planned or unplanned ICU admission
- extubation or death before protocol completion (7 days) constitute exclusion criteria after enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Small Intestinal Bacterial Overgrowth Syndrome in ICU Patients. An Observational Study
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.
Read the 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 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.
- Being tested
- Modified hydrogen breath test
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified hydrogen breath testDiagnostic test
Also called Hydrogen monitor Gastrolyzer / Gastro+TM (Bedfont® Scientific Ltd,) was used for expired hydrogen (eH2) testing.
A modified technique to obtain expired hydrogen from the ventilator tubes is performed. A connection with a valve attached to a collecting bag is inserted at the end of the expiratory limb of the breathing circuit for exhaled air collection.
| Study group | Role | What they receive |
|---|---|---|
| ICU patients | Adult ICU patients on mechanical ventilation Receives: Diagnostic Test: Modified hydrogen breath test |
What is being measured
The primary outcome is the main question the study is designed to answer.
SIBO prevalence
The proportion of ICU patients diagnosed with SIBO
Measured: From date of ICU admission to date of ICU discharge or date of death from any cause, whichever came first, assessed up to one month)
Secondary outcomes (3)
VAP (ventilator associated pneumonia)
The proportion of ICU patients diagnosed with VAP
Measured: From date of ICU admission to date of ICU discharge or date of death from any cause, whichever came first, assessed up to one month)
ICU LOS
ICU lenght of stay, days
Measured: From date of ICU admission to date of ICU discharge or date of death from any cause, whichever came first, assessed up to one month)
All-cause in-hospital mortality
Death due to any cause during ICU and hospital stay.
Measured: From date of ICU admission to date of ICU discharge or date of death from any cause, whichever came first, assessed up to one month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start19 Nov 2018
- Primary completion8 Jul 2019
- Study completion8 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Intestinal Bacterial OvergrowthStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ioannina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agathi Karakosta, University of Ioannina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765994
- Sponsor's protocol ID
- 207
- Status last verified
- Mar 2023
- First submitted
- 25 Feb 2023
- Last updated
- 13 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Small Intestinal Bacterial Overgrowth Syndrome in ICU Patients. An Observational Study
- ClinicalTrials.gov ID
- NCT05765994
- Acronym / sponsor ID
- 207
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of IoanninaUniversity, hospital or other
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- 8 Jul 2019 (actual)
- Study completion
- 8 Jul 2019 (actual)
- First posted
- 13 Mar 2023 (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.
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.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU patients | – | Diagnostic Test: Modified hydrogen breath testAdult ICU patients on mechanical ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult critically ill patients admitted to the ICU and in need of mechanical ventilation.
Key inclusion criteria (1 listed)
- critically ill patients, in need of mechanical ventilation with an expected ICU length of stay and expected mechanical ventilation duration of more than 48 hours
Key exclusion criteria (6 listed)
- abnormal hydrogen breath test on the day of ICU admission (Day 1)
- recent (up to four weeks before ICU admission) antimicrobial therapy or patients already receiving antimicrobial therapy on admission
- recent (up to four weeks before ICU admission) use of gastroprotective medication, probiotics and prokinetics
- patients with known gastrointestinal disease prior to admission
- recent abdominal surgery resulting in planned or unplanned ICU admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified hydrogen breath testAlso: Hydrogen monitor Gastrolyzer / Gastro+TM (Bedfont® Scientific Ltd,) was used for expired hydrogen (eH2) testing.A modified technique to obtain expired hydrogen from the ventilator tubes is performed. A connection with a valve attached to a collecting bag is inserted at the end of the expiratory limb of the breathing circuit for exhaled air collection. | Diagnostic test | ICU patients |
Primary outcome
SIBO prevalence
Time frame: From date of ICU admission to date of ICU discharge or date of death from any cause, whichever came first, assessed up to one month)
The proportion of ICU patients diagnosed with SIBO
3 secondary outcomes
VAP (ventilator associated pneumonia)
Time frame: From date of ICU admission to date of ICU discharge or date of death from any cause, whichever came first, assessed up to one month)
ICU LOS
Time frame: From date of ICU admission to date of ICU discharge or date of death from any cause, whichever came first, assessed up to one month)
All-cause in-hospital mortality
Time frame: From date of ICU admission to date of ICU discharge or date of death from any cause, whichever came first, assessed up to one month)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Intestinal Bacterial Overgrowth and Critical Illness, run by University of Ioannina at 1 site in Greece.
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 6 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: finished, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SIBO prevalence (time frame: From date of ICU admission to date of ICU discharge or date of death from any cause, whichever came first, assessed up to one month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2023.