Contact information
Type
Scientific
Primary contact
Dr Diny van Zoeren-Grobben
ORCID ID
Contact details
Isala Clinics
Neonatal Unit
Dr van Heesweg 2
Zwolle
8025 AB
Netherlands
+31 (0)38 424 7073
d.van.zoeren@isala.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
06-1178
Study information
Scientific title
Acronym
VIPP a terme
Study hypothesis
Supplementation of infant formula with a combination of pre- and probiotics may protect infants against infectious complications such as diarrhoea and respiratory infections. We speculate that the combination of pre- and probiotics is a better protective than only one of these substances. Supplementation of the combination of pre- and probiotics may reduce the incidence of infections to the same level as human milk-fed infants.
Ethics approval
Ethics approval received from the Medical Ethical Committee of the Isala Clinics according to article 16 WMO and according to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (ICH/GCP) criteria on the 8th February 2007 (ref: 06.1178).
Study design
Double blind placebo-controlled randomised prospective cohort study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Heathy term infants with intercurrent diseases: diarrhoea and respiratory infections
Intervention
Treatment consists of three types of infant formula:
1. Standard infant formula (frisolac 1) without addition of prebiotics or probiotics
2. Standard infant formula with addition of galacto-oligosaccharides (GOS); 0.8 g/100 ml (Vivinal Domo, The Netherlands. GOS 10 contains: galacto-oligosaccarides 28.5%, lactose 36%, glucose 9.5%, galactose 0.5%, proteins 17.5%, minerals 3.5%, fat 1.5%, moisture 3.0%)
3. Standard infant formula with addition of a mixture of prebiotics (GOS [the same as B]) and a probiotic mixture consisting of lactobacillus casei CRL 431 2 x 100,000/ml and bifidobacterium lactis BB 2 x 100,000/ml (Bioflora Pharma Nord, The Netherlands)
The total duration of treatment is 6 months, faeces samples will be taken at 6 weeks, 3 and 6 months. Questionnaires regarding frequency of diarrhoea, airway infection, and feeding tolerance will be filled in by the parents every 2 weeks during the study period (6 months). All questionnaires (e.g. regarding infections, faecal composition and feeding tolerance) are standardised. An outpatient visit for growth measurements will be held at 3 and 6 months.
Intervention type
Drug
Phase
Not Specified
Drug names
Prebiotics, probiotics
Primary outcome measures
1. Frequency, incidence and duration of diarrhoea and respiratory infections, measured during the first 6 months of life and evaluated by the questionnaires
2. Composition of gut flora, evaluated at week 6, 3 months and 6 months of life (during the period infants receive the study feeds)
Secondary outcome measures
1. Growth (head circumference, length and weight), measured in the out-patient clinic at 3 and 6 months
2. Feeding tolerance (pattern of defaecation, consistence of faeces, crying, vomiting, stomach ache), assessed with standardised questions
Overall trial start date
01/04/2007
Overall trial end date
01/04/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Healthy term infants with a post-menstrual age of 37 - 42 weeks, either sex
2. Birth weight between P10 and P90
3. Informed consent of both parents
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
Formula group: n = 225 (75 in every group). Reference group (human milk ) n = 150.
Participant exclusion criteria
1. Neonatal sepsis
2. Severe congenital malformations
3. Birth asphyxia (apgar less than six at 5 minutes, and/or umbilical cord pH less than 7.00 and/or necessity of reanimation)
4. Admission to a paediatric ward
5. No Dutch or English speaking parents
6. Antibiotics to the mother during labour
7. Antibiotics to the infant in the first week of life
8. History of allergy with parents or siblings
Recruitment start date
01/04/2007
Recruitment end date
01/04/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
Isala Clinics
Zwolle
8025 AB
Netherlands
Sponsor information
Organisation
Royal Friesland Foods B.V. (The Netherlands)
Sponsor details
c/o Dr R te Biesebeke
Enhanced Nutrition Specialist Unit
P.Stuyvesantweg 1
Leeuwarden
8937 AC
Netherlands
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Royal Friesland Foods B.V. (The 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