Synopsis

Baby Biotics is a double-blind randomised controlled trial of the probiotic, Lactobacillius reuteri, in 167 infants aged less than 3 months old with infant colic. The study will investigate the impact of L reuteri on infant crying and sleep, as well as maternal mental health and family quality of life.

Summary

 

Study name Baby Biotics
Current principal investigator/s Valerie Sung
Harriet Hiscock
Melissa Wake
Ralf Heine
Mimi Tang
Fiona Mensah
Amanda Stock
Current project manager Valerie Sung
Phone +61 3 9345 4363
Email Valerie.Sung@rch.org.au
Primary Institution Royal Children’s Hospital 
Collaborating Institution/s Royal Children’s Hospital- Centre for Community Child Health; Murdoch Childrens Research Institute; Equitee Trustees Charitable Trusts
Major funding sources Royal Children’s Hospital – Centre for Community Child Health
Murdoch Children’s Research Institute
Equitee Trustees Charitable Trusts
Study website http://www.rch.org.au/ccch/for_researchers/Baby_Biotics/
Key reference

Sung, V., Hiscock, H., Tang, M., Mensah, F.K., Heine, R.G., Stock, A., York, E., Barr, R.G. and Wake, M. (2012). Probiotics to improve outcomes of colic in the community: Protocol for the Baby Biotics randomised controlled trial. BMC Pediatr. 12:135. doi: 10.1186/1471-2431-12-135

Sung, V., Hiscock, H., Tang, M.L.K., Mensah, F.K., Nation, M.L., Satzke, C., Heine, R.G., Stock, A., Barr, R.G. and Wake, M. (2014). Treating infant colic with the probiotic Lactobacillus reuteri: double blind, placebo controlled randomised trial. BMJ : British Medical Journal, 348:g2107. doi: 10.1136/bmj.g2107

Are data available to others outside study team? With custodian approval
Study focus Effect of probiotic Lactobacillus reuteri  on infant colic and maternal mental health and family functioning.
Sampling frame Infants aged between 0-3 month, with infant colic.
Recruitment is from a range of services widely used by and readily accessible to parents seeking medical advice regarding their crying babies in Melbourne, Australia. These comprise: the Royal Children’s Hospital Emergency Department (RCH ED), the RCH Unsettled Babies clinic (a tertiary referral-based clinic for assessment and management of unsettled babies), Tweddle Child and Family Health Centre (a mother-infant parenting centre), two Maternal Child Health centres (universal nurse health checks in the Boroondara and Moonee Valley districts), and paediatricians at the RCH and in private practices. Interested families can also directly contact the study team to be involved.
Year commenced 2011
Commencement sample 167 
Intergenerational? No 
Imaging No 
Linkage No 
Biosamples? Faeces
Ethics approvals or requirements? This project only (Specific consent)
Future research related to this project (Extended consent)

Waves

Wave Year Age (mean, range) Eligible sample
1  2011 – 2012  Baseline <0 – 3 months 167
2  2011 – 2012  age + 7 days 167
3  2011 – 2012  age + 14 days 167 
4  2011 – 2012  age + 21 days 167 
5  2011 – 2012  age + 28 days 167 
6  2011 – 2012  6 months 167