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 |
|
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 |