Malnutrition Ondervoeding
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age ≥ 18 years; 2. Indication for enteral nutrition via a nasogastric tube or Percutaneous Endoscopic Gastrostomy (PEG); 3. Expected average daily intake of enteral nutrition at least 1000 kcal; 4. Expected to require enteral nutrition for at least 7 days after inclusion; 5. Written informed consent from patient.
Exclusion criteria
Exclusion criteria: 1. Tube nutrition in the past two weeks; 2. Gastrointestinal surgery in the past 2 weeks; 3. Surgery involving general anaesthesia in the past 2 weeks; 4. Requiring intensive care; 5. Ulcerative colitis or Crohn's disease; 6. Presence of colostomy or other faecal diversion; 7. Known intolerance or allergy to ingredients of study product; 8. Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements; 9. Participation in any other study involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gastrointestinal tolerance: 1. Defecation pattern; 2. Occurrence and intensity of gastrointestinal symptoms; 3. Number of days target amount of tube feed administration not reached due to signs of intolerance. | — |
Secondary
| Measure | Time frame |
|---|---|
| Study product intake. | — |
Contacts
Danone Research - Centre for Specialised Nutrition P.O.Box 7005