Probiotics to improve outcomes of colic in the community: Protocol for the Baby Biotics randomised controlled trial

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 ≥3？hours/day for ≥3？days/week for ≥3？weeks [1]. In research, the modified Wessel’s criteria of crying and/or fussing ≥3？hours/day for ≥3？days/week for