Pilot Study on Gastro-intestinal (GI) Enteral Nutrition (EN) Tolerance in Intensive Care Unit Patients

A Pilot Study to Evaluate the Effect of a Specific Enteral Formulation Designed to Improve Gastrointestinal Tolerance in the Critically Ill Patient

Specifically designed enteral formulations may improve the gastrointestinal tolerance during early enteral nutrition in the critically ill patient.

This pilot trial will permit testing the design of the full-scale study providing valuable data on the expected effect of the formulation, the variability, thus helping to better estimate the required sample size.

Inclusion Criteria:

• Male or female older than 18 years of age
• All ICU patients
• Expected ICU stay superior or equal to 5 days
• Anticipated to receive tube feeding for at least 3 days
• Informed consent obtained from patient or close relative

Exclusion Criteria:

• Contraindication to enteral nutrition or to the placement of an enteral feeding tube
• On enteral nutrition with superior or equal to 75% of caloric goal administered
• Restriction in full intestinal support including protein administration
• Parenteral nutrition of any kind unless due to enteral nutrition intolerance
• History of allergy or intolerance to the study product components (test or control product)
• Currently under therapeutic limitations. Non functional GI tract
• Unwilling or unable to comply with study treatments
• Currently participating or having participated in another clinical, interventional trial during the last month