title: Treating infant colic with the probiotic Lactobacillus reuteri: double blind, placebo controlled randomised trial.
abstract: OBJECTIVE
  To determine whether the probiotic Lactobacillus reuteri DSM 17938 reduces crying or fussing in a broad community based sample of breastfed infants and formula fed infants with colic aged less than 3 months.
  
  
  METHODS
  Double blind, placebo controlled randomised trial.
  
  
  METHODS
  Community based sample (primary and secondary level care centres) in Melbourne, Australia.
  
  
  METHODS
  167 breastfed infants or formula fed infants aged less than 3 months meeting Wessel's criteria for crying or fussing: 85 were randomised to receive probiotic and 82 to receive placebo.
  
  
  METHODS
  Oral daily L reuteri (1 × 10(8) colony forming units) versus placebo for one month.
  
  
  METHODS
  The primary outcome was daily duration of cry or fuss at 1 month. Secondary outcomes were duration of cry or fuss; number of cry or fuss episodes; sleep duration of infant at 7, 14, and 21 days, and 1 and 6 months; maternal mental health (Edinburgh postnatal depression subscale); family functioning (paediatric quality of life inventory), parent quality adjusted life years (assessment of quality of life) at 1 and 6 months; infant functioning (paediatric quality of life inventory) at 6 months; infant faecal microbiota (microbial diversity, colonisation with Escherichia coli), and calprotectin levels at 1 month. In intention to treat analyses the two groups were compared using regression models adjusted for potential confounders.
  
  
  RESULTS
  Of 167 infants randomised from August 2011 to August 2012, 127 (76%) were retained to primary outcome; of these, a subset was analysed for faecal microbial diversity, E coli colonisation, and calprotectin levels. Adherence was high. Mean daily cry or fuss time fell steadily in both groups. At 1 month, the probiotic group cried or fussed 49 minutes more than the placebo group (95% confidence interval 8 to 90 minutes, P=0.02); this mainly reflected more fussing, especially for formula fed infants. The groups were similar on all secondary outcomes. No study related adverse events occurred.
  
  
  CONCLUSIONS
  L reuteri DSM 17938 did not benefit a community sample of breastfed infants and formula fed infants with colic. These findings differ from previous smaller trials of selected populations and do not support a general recommendation for the use of probiotics to treat colic in infants.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN95287767.
authors.affiliation: Royal Children's Hospital, Parkville, Victoria, Australia.
authors.forename: Valerie
authors.initials: V
authors.lastname: Sung
authors.forename: Harriet
authors.initials: H
authors.lastname: Hiscock
authors.forename: Mimi L K
authors.initials: ML
authors.lastname: Tang
authors.forename: Fiona K
authors.initials: FK
authors.lastname: Mensah
authors.forename: Monica L
authors.initials: ML
authors.lastname: Nation
authors.forename: Catherine
authors.initials: C
authors.lastname: Satzke
authors.forename: Ralf G
authors.initials: RG
authors.lastname: Heine
authors.forename: Amanda
authors.initials: A
authors.lastname: Stock
authors.forename: Ronald G
authors.initials: RG
authors.lastname: Barr
authors.forename: Melissa
authors.initials: M
authors.lastname: Wake
mesh_terms: D003085:Colic / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007223:Infant; D018730:Infant Behavior; D052200:Limosilactobacillus reuteri / Q000378:metabolism*; D008297:Male; D019936:Probiotics / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome