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.

Phase 2

• Conditions: ondervoeding en andere redenen waarom een kind niet (genoeg) groeit.; Failure to thrive; Malnutrition; 10003018

• Registration Number: NL-OMON34977
• Lead Sponsor: Danone Research - Centre for Specialised Nutrition

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 19

Inclusion Criteria

- 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).

Exclusion Criteria

- 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified