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

Not Applicable

• Conditions: Enteral nutrition-associated diarrhoea; Diet and Nutrition - Other diet and nutrition disorders; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12612000644864
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients developing diarrhoea as classifed by the validated King's Stool Chart.[Within a seven-day study duration.]

Secondary Outcome Measures

Name	Time	Method
Proportion of patients ceasing enteral nutrition due to poor tolerance as determined by the treating medical team, such as gastrointestinal complaints or high level gastric aspirates.[Within a seven-day study duration.];Number of bowel motions during the day from day four of study.[Day four to seven of study.];Proportion of patients with gastrointestinal adverse events, such as reported symptoms of nausea or reflux.[Within a seven-day study duration.];Proportion of patients that meet target volume as specified by their treating dietitian.[Within a seven-day study duration.];Proportion of patients with diarrhoea from Clostridium difficile which will be assessed on development of diarrhoea. On the development of diarrhoea, faeces will be collected for microscopy, culture and Clostridium difficile toxin assessment through hospital pathology.[If diarrhoea develops within the seven-day study duration.]