Contact information
Type
Scientific
Primary contact
Dr Kate Costeloe
ORCID ID
Contact details
Neonatal Unit
Homerton University Hospital NHS Trust
Homerton Row
London
E9 6SR
United Kingdom
+44 (0)20 8510 7552
k.l.costeloe@qmul.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0024105932
Study information
Scientific title
Supplementation of very low birthweight (VLBW) babies with probiotic Bifidobacterium breve strain (BBG): a pilot study of tolerability and feasibility
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
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
Phase
Drug names
Primary outcome measures
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 trial start date
01/01/2002
Overall trial end date
31/12/2003
Reason abandoned
Eligibility
Participant inclusion criteria
Preterm babies more than 500 but less than 1500 g birthweight with no life threatening congenital malformations
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
40
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2002
Recruitment end date
31/12/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Homerton University Hospital NHS Trust
London
E9 6SR
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Homerton University Hospital NHS Trust (UK)
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