Baby Biotics

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.

Baby Biotics participants were followed up at 2-3 years old to understand the long-term impacts of colic on child behaviour and family functioning. Stool samples collected at baseline were also analysed to understand the relationship between gut microbiota and child behaviour.

Study Summary
Study name Baby Biotics
Study abbreviation 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/s The Royal Children’s Hospital - RCH
Collaborating Institution/s Murdoch Children’s Research Institute - MCRI
Major funding source/s The Centre for Community Child Health, Royal Children’s Hospital
Murdoch Children’s Research Institute - MCRI
Equitee Trustees Charitable Trusts
Key reference for study
Study focus

The primary focus of Baby Biotics is to measure the effect of probiotic Lactobacillus reuteri on infant colic and maternal mental health and family functioning. Secondary outcomes include: To measure the long-term outcomes of colic on child behaviour, and explore the association between gut microbiota and child behaviour.

Sampling frame

Infants aged between 0-3 month, with infant colic were recruited through a wide range of services accessible to parents seeking medical advice regarding their crying babies in Melbourne, Australia. These comprise of: 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.

Primary study type Randomised Control Trial / Other trial
Primary participant (at recruitment) Index child
Year commenced

2011

Is this study ongoing? No - the study is complete
Year study ended 2014
Ongoing recruitment? No
Sample size (N)

167 infants and their mothers

Survey data available? Yes
Imaging data available? No
Linkage to administrative dataset/s? No, no consent to link to administrative dataset(s) obtained
Biosamples available? Yes
Are data available to others outside study team, with appropriate safeguards and structures in line with the cohort’s ethics and governance processes? Yes
Are there any costs associated with data/sample access for approved requests? There are usually no costs associated with access
Broadest type of participant consent available Extended consent (can be used for future ethically approved research related to this project)
Phase Year Age Sample size (N)
Baseline 2011-2012 0-3 months N(Total)=167
7 days post-randomisation 2011-2012 0-3 months N(Total)=167
14 days post-randomisation 2011-2012 0-3 months N(Total)=167
21 days post-randomisation 2011-2012 0-3 months N(Total)=167
28 days post-randomisation 2011-2012 0-3 months N(Total)=154
6 month follow-up 2011-2012 6 months N(Total)=132
Toddler follow-up 2014 2-3 years N(Total)=124
Study Contacts
Principal investigator/s Valerie Sung
Harriet Hiscock
Melissa Wake
Ralf Heine
Mimi Tang
Fiona Mensah
Amanda Stock
Project manager

Valerie Sung

Study Contact

Phone: (03) 9345 4363
Email: baby.biotics@rch.org.au
Address: Baby Biotics, Centre for Community Child Health
Royal Children’s Hospital
Flemington Road, Parkville
Victoria 3052 Australia