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 designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleSupplementation of very low birthweight (VLBW) babies with probiotic Bifidobacterium breve strain (BBG): a pilot study of tolerability and feasibility
Study objectives1. 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) studiedNeonatal Diseases: Low birth weight
InterventionRandomised 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 typeSupplement
Primary outcome measureThus 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 measuresNot provided at time of registration
Overall study start date01/01/2002
Completion date31/12/2003

Eligibility

Participant type(s)Patient
Age groupNeonate
SexBoth
Target number of participants40
Key inclusion criteriaPreterm babies more than 500 but less than 1500 g birthweight with no life threatening congenital malformations
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/2002
Date of final enrolment31/12/2003

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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan