Condition category
Neonatal Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
19/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes