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 investigated the impact of L reuteri on infant crying and sleep, as well as maternal mental health and family quality of life.

Melbourne Children’s Consortium for Lifecourse Research Study 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
Primary institution Royal Children’s Hospital
Collaborating institution/s Murdoch Children’s Research Institute
Major funding sources Royal Children’s Hospital – Centre for Community Child Health
Murdoch Children’s Research Institute
Equitee Trustees Charitable Trusts
Study website
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

Bell G, Hiscock H, Tobin S, Cook F, Sung V. (2018). Behavioral outcomes of infant colic in toddlerhood: a longitudinal study. The Journal of Pediatrics. doi: 10.1016/j.jpeds.2018.05.010

Are data available to others outside study team? With custodian approval
Study focus (e.g. social development) 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.

Study type (e.g. randomised control trial, cohort, case-control) A phase III, double-blind, randomised placebo-controlled trial drawing on clinical and community based samples.
Year commenced 2011
Ongoing recruitment? No
Commencement sample 167
Intergenerational (e.g. offspring)? No
Imaging (e.g. fMRI, ultrasound, retinal photograph)? No
Linkage (e.g. BioGrid, VPDC, NAPLAN, Medicare)? No
Biosamples (e.g. buccal, blood, hair)? Faeces
Ethics approvals or requirements (e.g. specific, extended, unspecified, other)? This project only (Specific consent)
Future research related to this project (Extended consent)

Principal Investigator

Dr Valerie Sung

Ph: +61 3 9345 4363