Effect of prebiotic or lactoferrin supplementation in formula on the gut flora of preterm infants

ISRCTN	ISRCTN71737811
DOI	https://doi.org/10.1186/ISRCTN71737811
Secondary identifying numbers	06-1179

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: Nutritional, Metabolic, Endocrine

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 prematuur
Study objectives	Supplementation of preterm formula with prebiotics or lactoferrin may improve the gut flora of preterm infants by promoting growth of apathogenic bacteria. These supplements may produce a gut flora resembling the gut flora of human milk-fed preterm infants and thereby improve their resistance against infections. Furthermore lactoferrin reduces the availability and absorption of free iron and may thus reduce oxidative stress both locally in the gut and systemically.
Ethics approval(s)	Ethcis approval received from the Medical Ethical Committee of the Isala Clinics according to article 16 WMO and 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: 06.1179).
Health condition(s) or problem(s) studied	Gut flora
Intervention	Treatment consists of three types of preterm formula: 1. Standard preterm formula (frisolac prematuur) without addition of prebiotics 2. Standard preterm formula with addition of galacto-oligosaccharides (GOS); 0.8 g/100 ml (Vivinal Domo, The Netherlands. GOS 10 containing: 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 preterm formula with addition of dairy lactoferrin 1 mg/100 ml (Vivinal Domo, The Netherlands, containing lactoferrin 90 %, protein 97%, moisture 1.5%, minerals 1.5 %) The therapy wil be started in the first week of life and therapy will be continued until 6 weeks after the start of full enteral feeds. Blood will be drawn at day 1, day 7, day of full enteral feeds and week 6 after establishment of full enteral feeds. Follow up wil be done at the age of 1 year corrected age.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Prebiotic, lactoferrin
Primary outcome measure	1. Composition of gut flora, evaluated at 6 weeks of full enteral feeds (at the end of the study feeding) 2. Incidence of infections, measured at 6 weeks of full enteral feeds 3. Oxidative stress and iron status, measured at 6 weeks of full enteral feeds
Secondary outcome measures	1. Growth (head circumference, length, weight), measured at 6 weeks of full enteral feeds 2. Feeding tolerance (composition of faeces, crying pattern, discomfort, vomiting), measured at 6 weeks of full enteral feeds 3. Psychomotor development, taken at 1 year of age
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	Preterm formula group: n = 60 (20 in each group). Human milk group: n = 20.
Key inclusion criteria	1. Preterm infants: gestational age 26+0 to 35+6 weeks, either sex 2. Admitted to the Neonatal Intensive Care Unit (NICU) or High Care Unit of the hospital
Key exclusion criteria	1. Birth weight less than 600 g 2. Life-threatening congenital malformations 3. No Dutch or English speaking parents 4. History of allergy in 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