Supplementation of very low birthweight (VLBW) babies with probiotic Bifidobacterium breve strain (BBG): a pilot study of tolerability and feasibility

ISRCTN	ISRCTN99401619
DOI	https://doi.org/10.1186/ISRCTN99401619
Secondary identifying numbers	N0024105932

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 19/09/2016

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 Kate Costeloe
Scientific

Neonatal Unit
Homerton University Hospital NHS Trust
Homerton Row
London
E9 6SR
United Kingdom

Phone	+44 (0)20 8510 7552
Email	k.l.costeloe@qmul.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Supplementation of very low birthweight (VLBW) babies with probiotic Bifidobacterium breve strain (BBG): a pilot study of tolerability and feasibility
Study objectives	1. Are the available preparations of live Bifidobacterium breve (BBG) at doses of 0.5 x 10/9 colony forming units twice daily and the placebo (killed BBG), tolerated in the newborn baby less than 1500 g birthweight when started on the second day of life? 2. Is it feasible to administer these products on day two of life in this population? 3. Confirmation that this dose of BBG is adequate to achieve bowel colonisation 4. Is there a difference in stool Immunoglobulin A (IgA) concentration at 14 and 28 days of life in association with BBG supplement?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Neonatal Diseases: Low birth weight
Intervention	Randomised controlled trial, 20 per group to be fed live or killed BBG. Group A: Bifidobacterium breve live strain Group B: Placebo (BBG killed strain)
Intervention type	Supplement
Primary outcome measure	Thus is a pilot study of tolerability and feasibility. The main study will investigate whether BBG supplement is associated with reduced infection and antibiotic usage in this population.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/2002
Completion date	31/12/2003

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target number of participants	40
Key inclusion criteria	Preterm babies more than 500 but less than 1500 g birthweight with no life threatening congenital malformations
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/2002
Date of final enrolment	31/12/2003

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Homerton University Hospital NHS Trust

London
E9 6SR
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Government

Homerton University Hospital NHS Trust (UK)

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