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 |
| Protocol serial number | N0024105932 |
| Sponsor | Department of Health (UK) |
| Funder | Homerton University Hospital NHS Trust (UK) |
- 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
Scientific
Neonatal Unit
Homerton University Hospital NHS Trust
Homerton Row
London
E9 6SR
United Kingdom
| Phone | +44 (0)20 8510 7552 |
|---|---|
| k.l.costeloe@qmul.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | 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(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Homerton University Hospital NHS Trust
London
E9 6SR
United Kingdom
E9 6SR
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
