Randomised, controlled, open label, cross-over trial to evaluate the tolerance of a new smoothie-style paediatric sip feed in children in need of oral nutritional support. - PAT-trial

Danone Research - Centre for Specialised Nutrition0 个研究点目标入组 19 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

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•- Male and female subjects, aged 3-12 years (including 3 and 12 years) in need of oral nutritional support (subject can be current or new paediatric sip feed user).
•- Subject requires a paediatric sip feed for at least 6 weeks.
•- Both hospitalized subjects and out-patients.
•- Stable health status and expected to remain stable throughout the study (in the opinion of the Health Care Professional).
•- Written informed consent from parents/guardian and subject (if applicable according to local law).

•- Cow*s milk allergy, known inflammatory bowel disease, bowel resection.
•- Subjects requiring a fibre-free diet.
•- Known allergy for fruit (apple, pear, strawberry, raspberry, banana, apricot, lemon) and/or carrot.
•- Subjects requiring an adult rather than a paediatric sip feed.
•- Major renal dysfunction (if requiring, but not yet receiving, dialysis).
•- Major hepatic dysfunction (e.g. hepatitis, congenital abnormalities affecting the liver).
•- Major gastrointestinal intolerance (e.g. vomiting, diarrhoea).
•- Inherited metabolic disorders, including galactosaemia.
•- Use of parenteral feeding and/or enteral tube-feeding.
•- Investigator's uncertainty about the willingness or ability of the child/carer to comply with the protocol requirements.
•- Participation in any other study involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.

发起方

Danone Research - Centre for Specialised Nutrition