Journal article
Probiotics to improve outcomes of colic in the community: Protocol for the Baby Biotics randomised controlled trial
V Sung, H Hiscock, M Tang, FK Mensah, RG Heine, A Stock, E York, RG Barr, M Wake
BMC Pediatrics | Published : 2012
Abstract
Background: Infant colic, characterised by excessive crying/fussing for no apparent cause, affects up to 20% of infants under three months of age and is a great burden to families, health professionals and the health system. One promising approach to improving its management is the use of oral probiotics. The Baby Biotics trial aims to determine whether the probiotic Lactobacillus reuteri DSM 17938 is effective in reducing crying in infants less than three months old (<13.0 weeks) with infant colic when compared to placebo.Methods/Design: Design: Double-blind, placebo-controlled randomised trial in Melbourne, Australia. Participants: 160 breast and formula fed infants less than three months ..
View full abstractGrants
Awarded by National Health and Medical Research Council
Funding Acknowledgements
The trial is funded by the Equitee Trustees Georgina Menzies Maconcachie Charitable Trust and Australian National Health and Medical Research Council (NHMRC) Postgraduate Scholarship 607447, and part-supported by the Centre for Community Child Health at the Royal Children's Hospital. Murdoch Childrens Research Institute is supported by the Victorian Government's Operational Infrastructure Support Program. HH and MW are supported by NHMRC Population Health Career Development Awards (Grants 607351 and 546405). FM is supported by the NHMRC Population Health Capacity Building Grant 436914 and Early Career Fellowship 1037449. The investigational product and placebo are supplied and manufactured by BioGaia. Calpro AS supplied the CalproLab ELISA kits for the analysis of calprotectin levels. BioGaia, Calpro AS and Equitee Trustees are all independent of the study. BioGaia, Calpro AS and Equitee Trustees played no role in the trial's design, in the collection, analysis, and interpretation of data, in the writing of the manuscript, or in the decision to submit the manuscript for publication. We thank all families, maternal and child health nurses, doctors, paediatricians and research assistants (EY, Jane Sheehan, Saga Arthursson) who are taking part in the trial.