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The causes of infant colic (crying) are unclear, and its management options limited. Probiotics are live microorganisms that are of health benefit, and have been suggested to reduce crying in certain groups of infants with colic. The Baby Biotics Study is the largest randomised controlled trial in the world to show that probiotics are not effective for all infants with colic. A follow-up study is currently underway to determine the longterm outcomes of infant colic.
Infant colic, characterised by excessive crying of unknown cause, affects up to 20% of babies and doubles the risk of postnatal depression. It is the most common proximal risk factor for shaken baby syndrome, and is a huge burden to health services.
Caregivers of all participating infants filled out a short questionnaire at the beginning and at one and six months into the study. This questionnaire asked about the infants' and caregivers' general health and well-being. Caregivers also filled out a 48-hour infant behaviour diary once every week for four weeks. This diary recorded the infants' crying and sleeping patterns.
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Through a randomised controlled trial, we aimed to determine if the probiotic Lactobacillus reuteri can reduce infant crying and improve infant sleep, maternal mental health and family functioning in the critical first 6 months of life.
If effective, the simplicity of a probiotic as an intervention for infant colic is such that it could be widely taken up as a new standard of care in the primary and secondary care sectors. This would represent a major public health advance in reducing maternal mental illness, the risk of shaken baby syndrome, and expensive health service use such as parenting centres and mother-baby units.
Participants: 160 infants aged less than 3 months with infant colic. Families were recruited from the Unsettled Babies Clinic and the Emergency Department, Royal Children's Hospital, Melbourne and from the Tweddle Child and Family Health Centre, Footscray, and from the Boroondara and Moonee Valley Maternal Child Health Centres.
Methods: The study lasted for one month. During this time, half of the participating infants received five drops of probiotic liquid with their feeds every day. The other half received a placebo, that is, drops identical to the study liquid but without the probiotic.
At the beginning and at the end of the study, study researchers visited participating families at their homes, unless requested by families to have visits at the Royal Children's Hospital Melbourne. At these two visits, infants' stool (poo) samples were collected, and the questionnaires and diaries were collected. Study researchers called participating families every week to answer any questions about the study.
The Baby Biotics Study started in August 2011 and finished September 2012.
Double-blind randomised controlled trial.
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For results of the study
The Centre for Community Child Health is a department of The Royal Children’s Hospital and a research group of Murdoch Childrens Research Institute.