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Effect of Inulin supplementation on gastrointestinal microbiota in critical illness

Inulin supplementation and gastrointestinal microbiota outcomes in mechanically ventilated adults: a pilot randomized controlled trial (INTESTINAL)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000319471
Acronym
INTESTINAL
Enrollment
30
Registered
2025-04-17
Start date
2025-10-15
Completion date
2027-03-15
Last updated
2026-09-07

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

Conditions

None listed

Brief summary

This study will aim to establish whether dietary fibre added to normal tube feeding food can increase bacterial diversity in the GI tract in people who are critically ill and are receiving treatment with a breathing machine in the ICU. Information on GI bacteria will be collected from stool samples or cotton swabs that have wiped the bottom. It will also aim to collect information on whether the use of use of dietary fibre can lead to patients improving more quickly, such as by enabling liberation from the breathing machine earlier or having fewer infections caught in hospital. This study aims to investigate if "good bacteria" in the intestines can be increased during critical illness adding fibre to food.

Interventions

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

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.

Sponsors

Royal Melbourne Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

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

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Sep 19, 2026