NL-OMON53226
Completed
Not Applicable
Evaluation of the gastro-intestinal tolerance, nutritional intake, and acceptability of an upgraded composition of an enteral tube feed for adults in need of long term nutritional support - Peacock Butterfly
utricia Research0 sites50 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- indicatie voor sondevoeding
- Sponsor
- utricia Research
- Enrollment
- 50
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
- •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
Outcomes
Primary Outcomes
Not specified
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