indicatie voor sondevoeding in need of tube feed
Conditions
Interventions
Subjects will use their own current practice tube feed for 1 week (baseline
period) and will switch to the intervention tube feed with an adjusted
composition with a comparable energy density and fi
Sponsors
Nutricia Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years 2. Using either an enteral tube feed with approximately 1.0 or 1.5 kcal/mL with or without added fibers via a nasogastric tube (NGT), nasojejunal (NJT) or Percutaneous Endoscopic Gastrostomy (PEG) for at least 4 weeks prior to screening 3. Actual and expected average daily intake of enteral nutrition at least 1000 kcal for at least 21 days after the start of baseline period 4. Written informed consent from subject (or impartial witness after verbal consent of subject)
Exclusion criteria
Exclusion criteria: 1. Subjects receiving total parental feeding (TPN) 2. Gastro-intestinal surgery or any other surgery involving general anaesthesia within 2 weeks prior to screening 3. Subjects with major hepatic or renal dysfunction in the opinion of the Investigator 4. Subjects currently in the intensive care unit 5. Active/flare up condition of chronic illnesses in small or large intestines in the opinion of the Investigator (e.g., active inflammation/flare up of Crohn*s disease or ulcerative colitis) within 2 weeks prior to screening, 6. Subjects experiencing cancer treatment-related diarrhea within 2 weeks prior to screening 7. Presence of colostomy or other faecal diversion 8. Known intolerance or allergy to ingredients of study product (e.g. galactosemia, allergy to soy) 9. Inability of the subject to answer the study diary or questionnaires due to e.g., being unconscious, cognitive impairment, or dementia, in the opinion of the Investigator 10. Known pregnancy or lactation 11. Investigator*s uncertainty about the willingness or ability of the subject to comply with the protocol requirements 12. Active participation in any other clinical study involving investigational or marketed products concomitantly or within four weeks prior to entry into the study in the opinion of the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gastro-intestinal tolerance based on: - stool pattern defined as: consistency and frequency (use of Bristol Stool Form Scale) - GI tolerance symptom questionnaire including symptoms as nausea, vomiting, burping, constipation, diarrhea. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Volume of tube feeding administration - Product compliance - Acceptability of the product - Use of complementary feeding - Anthropometrics - Adverse events (frequency, type) - Medication use | — |
Countries
Netherlands
Outcome results
None listed