Small Intestinal Bacterial Overgrowth in Critically Ill Patients

NCT05765994 | Completed

• 1 other identifier: 207
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Small Intestinal Bacterial Overgrowth; Critical Illness; Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

• SIBO prevalence

  The proportion of ICU patients diagnosed with SIBO

  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)

  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

  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

  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)

Study Arms (1)

ICU patients

Adult ICU patients on mechanical ventilation

Diagnostic Test: Modified hydrogen breath test

Interventions

Modified hydrogen breath test DIAGNOSTIC_TEST

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.

Also known as: Hydrogen monitor Gastrolyzer / Gastro+TM (Bedfont® Scientific Ltd,) was used for expired hydrogen (eH2) testing.

ICU patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult critically ill patients admitted to the ICU and in need of mechanical ventilation.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ioannina: lead

Study Sites (1)

Univesity Hospital of Ioannina

Ioannina, Epirus, 45500, Greece

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anaesthesiology

Study Record Dates

• First Submitted: February 25, 2023
• First Posted: March 13, 2023
• Study Start: November 19, 2018
• Primary Completion: July 8, 2019
• Study Completion: July 8, 2019
• Last Updated: March 13, 2023

Record last verified: 2023-03

Locations

GR (1)