probiotics to improve outcomes of colic in the community protocol for the baby biotics randomised controlled trial益生菌改善结果社区协议对婴儿绞痛的生命学的随机对照试验.pdfVIP

Sung et al. BMC Pediatrics 2012, 12:135 /1471-2431/12/135 STUDY PROTOCOL Open Access Probiotics to improve outcomes of colic in the community: Protocol for the Baby Biotics randomised controlled trial 1,2,3* 1,2,3 2,3,4 2,3,5 2,3,4,6 7 Valerie Sung , Harriet Hiscock , Mimi Tang , Fiona K Mensah , Ralf G Heine , Amanda Stock , Elissa York1,2, Ronald G Barr8 and Melissa Wake1,2,3 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 old who present either to clinical or community services and meet Wessel’s criteria of crying and/or fussing. Intervention: Oral once-daily Lactobacillus reuteri (1x108 cfu) versus placebo for one month. Primary outcome: Infant crying/fussing time per 24 hours at one month. Secondary outcomes: i) number of episodes of infant crying/fussing per 24 hours and ii) infant sleep duration per 24 hours (at 7, 14, 21, 28 days and 6 months); iii) maternal mental health scores, iv) family functioning scores, v) parent quality adjusted life years scores, and vi) intervention cost-effectiveness (at one and six