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Design: Single centre randomised controlled trial.
Allocation: Computer generated random-digit randomisation.
Blinding: Participants, physicians and statisticians.
Setting: Tertiary hospital paediatric outpatient department, Turin, Italy, March 2008 to August 2009.
Patients: Breast-fed infants (n=46) aged 2–16 weeks with persistent crying fulfilling Wessel's criteria for colic: crying for more than 3 h/day for more than 3 days/week for more than 3 weeks.
Intervention: A 5 ml oil suspension of Lactobacillus reuteri or an identically appearing and tasting placebo oil.
Outcomes: Primary: Reduction in mean daily crying time at day 21 of treatment to less than 3 h/day. Secondary: Reduction in daily mean crying time to less than 50% of baseline at 7, 14 and 21 days.
Follow-up period: 21 days.
By day 21 median crying times were …
Correspondence to Dr Nick Brown, Paediatric Department, Salisbury District Hospital, Salisbury SP2 8BJ, UK;
Sources of funding BioGaia AB Stockholm, Sweden
Competing interests None.
Provenance and peer review Commissioned; internally peer reviewed.
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