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Open Access Highly Accessed Study protocol

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

Valerie Sung123*, Harriet Hiscock123, Mimi Tang234, Fiona K Mensah235, Ralf G Heine2346, Amanda Stock7, Elissa York12, Ronald G Barr8 and Melissa Wake123

Author Affiliations

1 Centre for Community Child Health, Royal Children’s Hospital, Parkville, Australia

2 Murdoch Childrens Research Institute, Parkville, Australia

3 Department of Paediatrics, University of Melbourne, Parkville, Australia

4 Department of Allergy and Immunology, Royal Children’s Hospital, Parkville, Australia

5 Clinical Epidemiology and Biostatistics Unit, Royal Children’s Hospital, Parkville, Australia

6 Department of Gastroenterology and Clinical Nutrition, Royal Children’s Hospital, Parkville, Australia

7 Emergency Department, Royal Children’s Hospital, Parkville, Australia

8 Developmental Neurosciences & Child Health, Child and Family Research Institute, BC Children's Hospital, Vancouver, Canada

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BMC Pediatrics 2012, 12:135  doi:10.1186/1471-2431-12-135

Published: 29 August 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 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.

Discussion

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.

Trial Registration

Current Controlled Trials ISRCTN95287767

Keywords:
Colic; Crying; Infant; Probiotics; Randomised controlled trial; Health care costs; Postpartum depression; Mental health; Quality of life; Biota