Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000319471
Ethics application status
Approved
Date submitted
28/11/2024
Date registered
17/04/2025
Date last updated
17/04/2025
Date data sharing statement initially provided
17/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Inulin supplementation on gastrointestinal microbiota in critical illness
Scientific title
Inulin supplementation and gastrointestinal microbiota outcomes in mechanically ventilated adults: a pilot randomized controlled trial (INTESTINAL)
Secondary ID [1] 313482 0
Nil
Universal Trial Number (UTN)
Trial acronym
INTESTINAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical illness 335894 0
Condition category
Condition code
Infection 332480 332480 0 0
Other infectious diseases
Respiratory 332481 332481 0 0
Other respiratory disorders / diseases
Cardiovascular 332482 332482 0 0
Other cardiovascular diseases
Neurological 332483 332483 0 0
Other neurological disorders
Renal and Urogenital 332484 332484 0 0
Kidney disease
Surgery 332485 332485 0 0
Other surgery
Oral and Gastrointestinal 332486 332486 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Metabolic and Endocrine 332487 332487 0 0
Metabolic disorders
Blood 332489 332489 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The dose administered: 10 grams of Inulin dissolved in 50mL of water.
The mode of administration: as a bolus through an existing nasogastric tube (or orally once extubated)
The frequency and duration of this intervention: once daily for 7 days (only while in ICU)
This intervention will commence as soon as possible after patient is mechanically ventilated, consent obtained from medical treatment decision maker (MDTM) and allowed enteral nutrition.
Adherence to administration of intervention will be by monitoring EMR.
Intervention code [1] 330057 0
Treatment: Other
Comparator / control treatment
50mL of water as a bolus through an existing nasogastric tube (or orally once extubated)
Control group
Placebo

Outcomes
Primary outcome [1] 340014 0
Intra-individual change to GI microbiota - Alpha diversity and/or increased abundance of SCFA-producing taxa (Roseburia, Ruminococcus, Faecalibacterium, Bifidobacteria) will be assessed as a composite outcome
Timepoint [1] 340014 0
Baseline (on randomisation), day 3 and day 7 post randomisation.
Secondary outcome [1] 442335 0
Incidence of diarrhoea (days of diarrhoea) and incident use of faecal management system; this will be assessed as a composite outcome.
Timepoint [1] 442335 0
Data for 7-day study period will be extracted at Day 7 post-commencement of intervention
Secondary outcome [2] 442336 0
Prevalence of enteral feed intolerance
Timepoint [2] 442336 0
Data for 7-day study period will be extracted at Day 7 post-commencement of intervention
Secondary outcome [3] 442337 0
Prevalence of symptoms or features consistent with excessive gas formation in the abdomen such as abdominal distension, bowel obstruction or ileus
Timepoint [3] 442337 0
Data for 7-day study period will be extracted at Day 7 post-commencement of intervention

Eligibility
Key inclusion criteria
a. Adults greater than or equal to 18 years of age
b. Admitted to ICU
c. Expected to remain Mechanically ventilated for 48 hrs
d. Allowed enteral nutrition at the time of randomization
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a. Death during ICU admission deemed to be inevitable
b. Patients unable to be fed enterally
c. Pregnancy
d. Surgery involving the GI lumen in the preceding 30 days
e. Currently has a colostomy or ileostomy
f. Pregnancy or lactation
g. Has received enteral nutrition for more than 72 hrs prior to randomisation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
central, variable block size via online randomisation engine
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/05/2025
Actual
Date of last participant enrolment
Anticipated
5/06/2028
Actual
Date of last data collection
Anticipated
30/06/2028
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 317923 0
Hospital
Name [1] 317923 0
The Northern Hospital
Country [1] 317923 0
Australia
Funding source category [2] 318709 0
Hospital
Name [2] 318709 0
Royal Melbourne Hospital
Country [2] 318709 0
Australia
Funding source category [3] 318710 0
Other Collaborative groups
Name [3] 318710 0
The Doherty Institute
Country [3] 318710 0
Australia
Primary sponsor type
Hospital
Name
Royal Melbourne Hospital
Address
Country
Australia
Secondary sponsor category [1] 321139 0
None
Name [1] 321139 0
Address [1] 321139 0
Country [1] 321139 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316608 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 316608 0
Ethics committee country [1] 316608 0
Australia
Date submitted for ethics approval [1] 316608 0
28/09/2024
Approval date [1] 316608 0
11/11/2024
Ethics approval number [1] 316608 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138402 0
Dr ANGAJ GHOSH
Address 138402 0
The Northern Hospital, 185 COOPER STREET, EPPING, VICTORIA 3076
Country 138402 0
Australia
Phone 138402 0
+61 03 8468 8264
Fax 138402 0
Email 138402 0
[email protected]
Contact person for public queries
Name 138403 0
ANGAJ GHOSH
Address 138403 0
The Northern Hospital, 185 COOPER STREET, EPPING, VICTORIA 3076
Country 138403 0
Australia
Phone 138403 0
+61 03 8468 8264
Fax 138403 0
Email 138403 0
[email protected]
Contact person for scientific queries
Name 138404 0
ANGAJ GHOSH
Address 138404 0
The Northern Hospital, 185 COOPER STREET, EPPING, VICTORIA 3076
Country 138404 0
Australia
Phone 138404 0
+61 03 8468 8264
Fax 138404 0
Email 138404 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.