Children requiring a paediatric peptide feed for at least 8 weeks. This can be due to causes such as inflammatory bowel disease, short bowel syndrome, pancreas/liver disease, chronic diarrhoea, cystic fibrosis, undiagnosed gut problems, coeliac disease.
Conditions
Interventions
After baseline measurements, patients receive either their current feed (= control) for 4 weeks followed by 4 weeks paediatric peptide feed, or paediatric peptide feed for 4 weeks followed by 4 weeks
Sponsors
Numico Research B.V.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children requiring a paediatric peptide feed. Some conditions where this is required may include inflammatory bowel disease, short bowel syndrome, pancreas/liver disease, chronic diarrhoea, cystic fibrosis, undiagnosed gut problems, coeliac disease; 2. Approximately 8-30 kg in weight; 3. Peptide based feed prescribed for at least 50% of daily energy requirements; 4. Expected need of peptide based feed for a minimum of 2 months; 5. Written parental informed consent.
Exclusion criteria
Exclusion criteria: 1. Unsuitable for infants under 1 year of age; 2. Children receiving parenteral nutrition for more than 50% energy requirements; 3. Children with galactosaemia; 4. Children with cow milk allergy; 5. Children with medical or dietary contraindication; 6. If the investigator is, for any reason, uncertain about the willingness to comply with the protocol requirements, the subject can be excluded; 7. Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study; 8. Multiple allergies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total score on questionnaire on gastro-intestinal tolerance: diarrhea, constipation, nausea, vomiting, abdominal distention, flatulence and burping of paediatric peptide feed versus control feeds. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Stool output (frequency, volume and consistency) of paediatric peptide feed versus control feeds; 2. Mean change in weight (kg) of paediatric peptide feed versus control feeds; 3. Mean change in growth, expressed as z-scores for weight and height (head circumference for children younger than two years old) of paediatric peptide feed versus control feeds; 4. Mean change in triceps skin fold thickness and mid arm circumference of paediatric peptide feed versus control feeds; 5. Blood concentrations of serum albumin, hemoglobin, haematocrit and c-reactive protein (CRP) of paediatric peptide feed versus control feeds; 6. Convenience/ease of use of paediatric peptide feed versus control feeds; 7. Dietary intake of paediatric peptide feed versus control feeds. | — |
Contacts
Public ContactMaartje Jansen
Numico Research B.V., P.O. Box 7005
Outcome results
None listed