Randomised, controlled, open label, cross-over trial to evaluate the tolerance of a new paediatric sip feed in children in need of oral nutritional support.
Recruiting
- Conditions
- Children in need of oral nutritional support
- Registration Number
- NL-OMON26666
- Lead Sponsor
- Danone Research – Centre for Specialised Nutrition
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 28
Inclusion Criteria
1. 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);
2. Subject requires a paediatric sip feed for at least 6 weeks;
Exclusion Criteria
1. Cow’s milk allergy, known inflammatory bowel diseases, bowel resection;
2. Subjects requiring a fibre-free diet;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tolerance: Daily stool frequency (with diary) and frequency and intensity of gastro-intestinal symptoms (with questionnaire).
- Secondary Outcome Measures
Name Time Method 1. Product appreciation: Overall liking and product evaluation carer (both with questionnaire);<br /><br>2. Daily study product intake (with diary).