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.
|Study name||Baby Biotics|
|Current principal investigator/s||Valerie Sung
|Current project manager||Valerie Sung|
|Phone||+61 3 9345 4363|
|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
|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 months, 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.
|Ethics approvals or requirements?||This project only (Specific consent)
Future research related to this project (Extended consent)
|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||154|
|6||2011 – 2012||6 months||132|