Modulation of gut function using Gut Specific Nutrients in the critically ill

Modulation of gut function using gut specific nutrients in the critically ill: a double blind, placebo controlled, randomised clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN61157513

Enrollment

Registered

2009-04-30

Start date

2004-03-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Gut failure Digestive System Other diseases of digestive system

Interventions

Enrolled patients were randomised to either a control group (receiving placebo) or a study group (receiving a gut specific nutrient cocktail of glutamine, multivitamins and antioxidants [Forceval], pr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Critically ill patients (aged greater than or equal to 18 years, either sex) with inadequate gut function

Exclusion criteria

Exclusion criteria: 1. Failure to obtain consent (or assent by the next-of-kin) 2. Known intolerance to one or more of the study preparations 3. Aged less than 18 years 4. Pregnancy 5. Patients who are strictly 'nil-by-mouth' and therefore unable to receive the study preparations or appropriate placebos

Design outcomes

Primary

Measure	Time frame
Time to the return of normal gut function, measured hourly from recruitment to return of gut function.	—

Secondary

Measure	Time frame
1. Episodes of feed intolerance, measured daily for duration of stay 2. Numerous nutritional parameters 3. Use of opiates, total quantity measured for duration of stay, day 30 and day 90 4. Fluid balance, measured daily for duration of stay 5. The need for surgery, measured daily for duration of stay, on day 30 and day 90 6. Duration of intravenous infusions, measured daily for duration of stay 7. Serial intestinal permeability, measured on recruitment, on day 30 and day 90 8. Serial Acute Physiology and Chronic Health Evaluation II (APACHE II) scores, measured on recruitment, weekly during admission, on day 30 and day 90 9. Other single organ failures, measured daily for duration of stay, on day 30 and day 90 10. Occurrence of septic, non-septic, and feed-related complications, measured daily for duration of stay, as well as mortality (measured throughout the 90 day follow-up period) and length of ICU and hospital stay (measured on discharge from ICU/hospital) 11. Need for patient readmission, measured after discharge to day 90 12. Total number of general practitioner (GP) visits, measured after discharge to day 90 13. Anthropometric measurements, measured on recruitment, weekly during admission, on day 30 and day 90 14. Hospital anxiety and depression (HAD) scores, measured on recruitment and then on day 30 and day 90 15. Pain and fatigue scores, measured on recruitment, weekly during admission, on day 30 and day 90	—

Measure

Time frame

1. Episodes of feed intolerance, measured daily for duration of stay 2. Numerous nutritional parameters 3. Use of opiates, total quantity measured for duration of stay, day 30 and day 90 4. Fluid balance, measured daily for duration of stay 5. The need for surgery, measured daily for duration of stay, on day 30 and day 90 6. Duration of intravenous infusions, measured daily for duration of stay 7. Serial intestinal permeability, measured on recruitment, on day 30 and day 90 8. Serial Acute Physiology and Chronic Health Evaluation II (APACHE II) scores, measured on recruitment, weekly during admission, on day 30 and day 90 9. Other single organ failures, measured daily for duration of stay, on day 30 and day 90 10. Occurrence of septic, non-septic, and feed-related complications, measured daily for duration of stay, as well as mortality (measured throughout the 90 day follow-up period) and length of ICU and hospital stay (measured on discharge from ICU/hospital) 11. Need for patient readmission, measured after discharge to day 90 12. Total number of general practitioner (GP) visits, measured after discharge to day 90 13. Anthropometric measurements, measured on recruitment, weekly during admission, on day 30 and day 90 14. Hospital anxiety and depression (HAD) scores, measured on recruitment and then on day 30 and day 90 15. Pain and fatigue scores, measured on recruitment, weekly during admission, on day 30 and day 90

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 30, 2026