%0 Journal Article
%T Probiotics to improve outcomes of colic in the community: Protocol for the Baby Biotics randomised controlled trial
%A Valerie Sung
%A Harriet Hiscock
%A Mimi Tang
%A Fiona K Mensah
%A Ralf G Heine
%A Amanda Stock
%A Elissa York
%A Ronald G Barr
%A Melissa Wake
%J BMC Pediatrics
%D 2012
%I BioMed Central
%R 10.1186/1471-2431-12-135
%X 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£¿months); and vii) infant faecal microbiota diversity, viii) infant faecal calprotectin levels and ix) Eschericia coli load (at one£¿month only). Analysis: Primary and secondary outcomes for the intervention versus control groups will be compared with t tests and non-parametric tests for continuous data and chi squared tests for dichotomous data. Regression models will be used to adjust for potential confounding factors. Intention-to-treat analysis will be applied.An effective, practical and acceptable intervention for infant colic would represent a major clinical advance. Because our trial includes breast and formula-fed babies, our results should generalise to most babies with colic. If cost-effective, the intervention¡¯s simplicity is such that it could be widely taken up as a new standard of care in the primary and secondary care sectors.Current Controlled Trials ISRCTN95287767Infant colic, characterised by excessive crying/fussing for no apparent cause, is common and distressing to families. Infant colic is defined clinically by Wessel¡¯s criteria of crying and/or fussing ¡İ3£¿hours/day for ¡İ3£¿days/week for ¡İ3£¿weeks [1]. In research, the modified Wessel¡¯s criteria of crying and/or fussing ¡İ3£¿hours/day for ¡İ3£¿days/week for
%K Colic
%K Crying
%K Infant
%K Probiotics
%K Randomised controlled trial
%K Health care costs
%K Postpartum depression
%K Mental health
%K Quality of life
%K Biota
%U http://www.biomedcentral.com/1471-2431/12/135