LifeCourse A Melbourne Children's Research Initiative

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.

Year	2011-2012	2011-2012	2011-2012	2011-2012	2011-2012	2011-2012	2014
Phase	Baseline	7 days post-randomisation	14 days post-randomisation	21 days post-randomisation	28 days post-randomisation	6 month follow-up	Toddler follow-up
Age	0-3 months	0-3 months	0-3 months	0-3 months	0-3 months	6 months	2-3 years
N	167	167	167	167	154	132	124
RELEVANT LIFECOURSE DOMAINS	Allergies
	Anthropometrics
	Bioanalyses and omics				Bioanalyses and omics
	Biosamples				Biosamples
	Community environment				Community environment
	Demographics
	Education and childcare
	Environmental exposures
	Family environment				Family environment
	Health services
	Medications and supplements
	Mental health and behaviour problems
	Methodology
						Neurocognitive development
	Nutrition
	Other health information
	Pregnancy and birth
	Psychosocial wellbeing				Psychosocial wellbeing
	Respiratory health
	Sleep						Sleep
	Substance use
	Temperament and personality					Temperament and personality

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	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 Loughman, A., Quinn, T., Nation, M.L., Reichelt, A., Moore, R.J., Van, T.T.H., Sung, V. and Tang, M.L.K. (2020). Infant microbiota in colic: predictive associations with problem crying and subsequent child behavior. J Dev Orig Health Dis: 1-11. doi:10.1017/s2040174420000227
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)

2012

Sung V, Hiscock H, Tang M, Mensah FK, Heine RG, Stock A, York E, Barr RG, 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

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