Condition category
Neonatal Diseases
Date applied
09/05/2008
Date assigned
12/09/2008
Last edited
12/09/2008
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 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

http://www.frieslandfoods.com

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

Publication citations

Additional files

Editorial Notes