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 个研究点目标入组 50 人开始时间: 待定最近更新: 2024年6月18日

适应症

试验速览

暂无简介。

•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)

•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

发起方

utricia Research