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 will investigate the impact of L reuteri on infant crying and sleep, as well as maternal mental health and family quality of life.
| Year | 2011-2012 | 2011-2012 | 2011-2012 | 2011-2012 | 2011-2012 | 2011-2012 |
|---|---|---|---|---|---|---|
| Wave | W1 | W2 | W3 | W4 | W5 | W6 |
| Age | baseline < 0-3 months | age + 7 days | age + 14 days | age + 21 days | age + 28 days | 6 months |
| # | 167 | 167 | 167 | 167 | 167 | 167 |
| Identifiers | Identifiers | |||||
| Allergies | ||||||
| Anthropometrics | ||||||
| Behavioural problems | ||||||
| Birth | ||||||
| Demographics | ||||||
| Environmental exposures (toxins and allergens) | ||||||
| General health | ||||||
| Medications | ||||||
| Mental health | Mental health | |||||
| Neuro-cognitive development | ||||||
| Nutrition | ||||||
| Relationships | Relationships | |||||
| Respiratory health | Respiratory health | |||||
| Sleep | ||||||
| Study treatment | ||||||
| Substance use | ||||||
| Temperament and personality | Temperament and personality | |||||
| Biosamples | Biosamples | |||||
| 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 | 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 (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) |