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

• Main Authors: Sung Valerie (Author), Hiscock Harriet (Author), Tang Mimi (Author), Mensah Fiona K (Author), Heine Ralf G (Author), Stock Amanda (Author), York Elissa (Author), Barr Ronald G (Author), Wake Melissa (Author)
• Format: Book
• Published: BMC, 2012-08-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.
• Notes: 10.1186/1471-2431-12-135; 1471-2431
• Keywords: Colic; Crying; Infant; Probiotics; Randomised controlled trial; Health care costs; Postpartum depression; Mental health; Quality of life; Biota; Pediatrics; RJ1-570
• Source: BMC Pediatrics, Vol 12, Iss 1, p 135 (2012)

<p>Abstract</p> <p>Background</p> <p>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 <it>Baby Biotics</it> trial aims to determine whether the probiotic <it>Lactobacillus reuteri DSM 17938</it> is effective in reducing crying in infants less than three months old (<13.0 weeks) with infant colic when compared to placebo.</p> <p>Methods/Design</p> <p><it>Design:</it> Double-blind, placebo-controlled randomised trial in Melbourne, Australia. <it>Participants:</it> 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. <it>Intervention:</it> Oral once-daily <it>Lactobacillus reuteri</it> (1x10⁸ cfu) versus placebo for one month. <it>Primary outcome:</it> Infant crying/fussing time per 24 hours at one month. <it>Secondary outcomes:</it> 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) <it>Eschericia coli</it> load (at one month only). <it>Analysis:</it> 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.</p> <p>Discussion</p> <p>An effective, practical and acceptable intervention for infant colic would represent a major clinical advance. Because our trial includes breast <it>and</it> 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.</p> <p>Trial Registration</p> <p>Current Controlled Trials ISRCTN95287767</p>