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Intestinal permeability 'leaky gut' in critically ill patients

Efficacy of using intestinal permeability as a tool to monitor clinical progress in the critically ill

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001101471
Enrollment
22
Registered
2016-08-15
Start date
2014-10-24
Completion date
2017-01-10
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Increased intestinal permeability, often referred to as ‘leaky gut’, is a measure of integrity and functioning of the mucosal (innermost) lining of the gastrointestinal tract. Increased levels have been found to correlate with the development of sepsis in the Intensive Care Unit. The location of increased intestinal permeability (gastroduodenal, small bowel and whole gut permeability) has not been adequately explored in the Intensive Care Unit. The aim of the study is to determine the location and degree of changes in intestinal permeability in mechanically ventilated critically ill adult patients. Additionally, this study aims to investigate the association between intestinal permeability, inflammation and clinical outcomes. Findings will be compared to data from healthy subjects being recruited in a separate study at La Trobe University (Request ID: 371028).

Interventions

The degree and location of intestinal permeability will be measured within 72 hours of admission to the Intensive Care Unit and repeated on day 5-6. Baseline urine and blood samples will be collected immediately prior to each test. Intestinal permeability will be measured by administering a sugar solution (1g sucrose, 0.5g rhamnose, 1g mannitol, 1g lactulose, 1g erythritol and 1g sucralose dissolved in 50ml of water) via an enteral feeding tube. A 24 hour urine collection will be conducted follo

The degree and location of intestinal permeability will be measured within 72 hours of admission to the Intensive Care Unit and repeated on day 5-6. Baseline urine and blood samples will be collected immediately prior to each test. Intestinal permeability will be measured by administering a sugar solution (1g sucrose, 0.5g rhamnose, 1g mannitol, 1g lactulose, 1g erythritol and 1g sucralose dissolved in 50ml of water) via an enteral feeding tube. A 24 hour urine collection will be conducted following the administration of the sugar solution. The concentration and ratios of select sugars will be analysed in urine samples using gas chromatography- mass spectrometry. Inflammation will be analysed using blood samples. Findings will be compared to results from healthy subjects in a separate study being conducted at La Trobe University (Request ID: 371028).

Sponsors

La Trobe University
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Primary purpose
Diagnosis

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

- Adult patients aged greater than or equal to 18 years; - Patients receiving or suitable for enteral feeding; - Likely to be admitted to the ICU for greater than or equal to 3 days; - Likely to require mechanical ventilation for > 24 hours; - Patients with an indwelling catheter in situ; - Patients receiving inotropic or vasopressor support at time of enrolment.

Exclusion criteria

- A past history of gut abnormalities, abdominal surgery within 2 years of ICU admission or malabsorption syndromes; - Presenting condition or past history of abdominal trauma within 2 years of admission; - Patients treated with therapeutic hypothermia during admission; - Patients requiring continuous renal replacement therapy; - Patients treated with non-steroidal anti-inflammatory drugs; - Any situation where lactulose or any of the test sugars are used as part of the treatment plan; - Patients receiving total parenteral nutrition or enteral feeding directly into the small bowel; - Patients receiving or received chemotherapy or radiotherapy in the past 6 months; - Pregnancy; - When participation in the study is not believed to be in the best interest of the patient as determined by the treating physician.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026