Condition category
Nutritional, Metabolic, Endocrine
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
03/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Maartje Jansen

ORCID ID

Contact details

Numico Research B.V.
P.O. Box 7005
Wageningen
6700 CA
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR451; 100027

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Received from local medical ethics committee

Study design

Multicentre, randomised, single blind, active controlled, crossover trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Paediatric peptide feed

Intervention

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 on the control feed. After 4 weeks and after 8 weeks, children return to the clinic where the outcome measures are assessed. Children are invited to participate in a 3-month open extension of the study.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Total score on questionnaire on gastro-intestinal tolerance: diarrhoea, constipation, nausea, vomiting, abdominal distention, flatulence and burping of paediatric peptide feed versus control feeds.

Secondary outcome measures

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, haemoglobin, 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

Overall trial start date

01/10/2005

Overall trial end date

01/10/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

24

Participant exclusion criteria

1. 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

Recruitment start date

01/10/2005

Recruitment end date

01/10/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Numico Research B.V.
Wageningen
6700 CA
Netherlands

Sponsor information

Organisation

Numico Research B.V. (Netherlands)

Sponsor details

P.O. Box 7005
Wageningen
6700 CA
Netherlands

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Numico Research B.V. (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes