None listed
Conditions
Brief summary
This pilot study aims to develop a new approach to improve protection against pneumococcal disease, using a probiotic (Bifidobacterium Bi-07) to boost immune responses to and reduce invasion by the pneumococcal bacteria. We are particularly interested in whether Bifidobacterium lactis Bi-07 given early in life, together with vaccination, can improve protection against pneumococcal infection and therefore reduce disease. This study will involve 30 babies and the use of Bifidobacterium lactis Bi-07 is currently experimental.
Interventions
To evaluate the adjuvant effect of B.lactis Bi-07 on the immune response to pneumococcal conjugate (PCV13) vaccination in healthy infants.
The probiotic powder is freeze-dried Bifidobacterium Bi-07 and silicon dioxide.The probiotic will be mixed with 10mls of cooled boiled water and administered orally via a syringe. Packaged in 1.0 gram white sachets, 100 per carton. The probiotic will be administered once daily.
Once infants have been recruited, the study period will be 6 months from the fi
To evaluate the adjuvant effect of B.lactis Bi-07 on the immune response to pneumococcal conjugate (PCV13) vaccination in healthy infants. The probiotic powder is freeze-dried Bifidobacterium Bi-07 and silicon dioxide.The probiotic will be mixed with 10mls of cooled boiled water and administered orally via a syringe. Packaged in 1.0 gram white sachets, 100 per carton. The probiotic will be administered once daily. Once infants have been recruited, the study period will be 6 months from the first day of treatment (at 4 weeks of age) until 7 months of age which spans the 3-dose PCV13 schedule (at 2,4,6 months). Compliance to the probiotic treatment will be monitored by a study diary that will completed by the parents/guardians on a daily basis. As this is a pilot study, we will also be able to determine feasibility of compliance during the study period and develop appropriate strategies to maintain this.
Sponsors
Associate Professor Mimi Tang
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
4 Weeks to 7 Months
Healthy volunteers
Yes
Inclusion criteria
1) Healthy, term infants (post-delivery) will be recruited from the postnatal maternity ward at the Royal Women's Hospital, Melbourne. 2 )The infant must be 4 weeks of age. 3) The infant must be born via a vaginal birth at 37 weeks or greater gestation. 4) The mother cannot have been on antibiotic treatment 2 weeks prior to delivery.
Exclusion criteria
1) Mothers who were taking probiotics during pregnancy or are on probiotic supplements. 2) Mothers who have a proven or suspected immunodeficiency. 3) Infants must not have had a probiotic. 4) Infants who have a significant foetal abnormality. 5) Infants who have or a proven or suspected immunodeficiency. 6)Significant maternal illness or disability such that study participation would impose an unacceptable additional burden. 7) Planning or likely to leave the area before the study finishes.
Outcome results
None listed