Management of diarrhoea in tube-fed patients by providing formula low in poorly absorbed sugars (Fermentable Oligosaccharides, Disaccharides, Monosaccharides And Polyols or FODMAPs)

Management of diarrhoea in patients receiving enteral nutrition by reducing intake of poorly absorbed short-chain carbohydrates (FODMAPs)

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000644864

Enrollment

100

Registered

2012-06-18

Start date

2012-07-02

Completion date

Unknown

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

This study aims to provide patients receiving enteral nutrition with a lower or higher FODMAP formula and monitor the proportion of patients that develop diarrhoea. We hypothesise that the lower FODMAP formula will prevent the development of diarrhoea.

Interventions

Providing patients receiving enteral nutrition with a standard enteral formula (that is in current use in Australia) of either lower or higher FODMAP (Fermentable Oligosaccharides, Disaccharides, Monosaccharides And Polyols) content. The FODMAP content of the lower formula is 11.9g/L and the higher is 48.2g/L. The enteral nutrition regimen including required dose and mode of delivery will be prescribed by the unit dietitian. The study duration will be for up to seven days or the development o

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Inpatients requiring enteral nutrition to provide at least 75% estimated nutritional requirements as determined by the assessing dietitian.

Exclusion criteria

1. Pre-existing diarrhoea 2. Enteral nutrition delivered directly into the jejunum 3. Patients with co-morbidities that predisposes them to diarrhoea, such as inflammatory bowel disease or previous intestinal resectional surgery 4. Patients anticipated to receive enteral nutrition in hospital for less than three days 5. Gastrointestinal surgery during current hospital admission 6. Patients admitted due to complication of gastrointestinal surgery 7. Patients requiring specialty enteral formula/regimen 8. Patients with psychiatric illness including anorexia nervosa

Outcome results