The role of pre- and probiotics in infections in term infants (De role van pre- en probiotica in infecties in a terme geboren kinderen)

ISRCTN	ISRCTN65140085
DOI	https://doi.org/10.1186/ISRCTN65140085
Secondary identifying numbers	06-1178

Submission date: 09/05/2008
Registration date: 12/09/2008
Last edited: 12/09/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Neonatal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Diny van Zoeren-Grobben
Scientific

Isala Clinics
Neonatal Unit
Dr van Heesweg 2
Zwolle
8025 AB
Netherlands

Phone	+31 (0)38 424 7073
Email	d.van.zoeren@isala.nl

Study information

Study design	Double blind placebo-controlled randomised prospective cohort study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronym	VIPP a terme
Study objectives	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(s)	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).
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Prebiotics, probiotics
Primary outcome measure	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 study start date	01/04/2007
Completion date	01/04/2009

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	Both
Target number of participants	Formula group: n = 225 (75 in every group). Reference group (human milk ) n = 150.
Key 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
Key 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
Date of first enrolment	01/04/2007
Date of final enrolment	01/04/2009

Locations

Countries of recruitment

Netherlands

Study participating centre

Isala Clinics

Zwolle
8025 AB
Netherlands

Sponsor information

Royal Friesland Foods B.V. (The Netherlands)
Industry

c/o Dr R te Biesebeke
Enhanced Nutrition Specialist Unit
P.Stuyvesantweg 1
Leeuwarden
8937 AC
Netherlands

Website	http://www.frieslandfoods.com
"ROR"	https://ror.org/025mtxh67

Funders

Funder type

Industry

Royal Friesland Foods B.V. (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan