Table 1 Characteristics of trials included in the analysis
Study/year/reference | Description/study design | Birth weight and age at enrolment | Probiotic agent(s) | Dosage and duration | Control arm | Primary outcome |
|---|---|---|---|---|---|---|
Savino/2007 [24] | April 2004 - May 2005. | Birth weight 2500-4000 g and aged 21–90 days | L. reuteri (American Type Culture Collection Strain 55730) | 108 colony-forming units in 5 drops for 28 days | Simethicone | A reduction of average crying time to less than 3 hours a day on day 28. |
90 exclusively breastfed infants with a diagnosis of infantile colic. | ||||||
Recruited in the Department of Pediatric and Adolescence Science (Regina Margherita Children Hospital, Turin, Italy) | ||||||
Open prospective randomized study. | ||||||
Savino/2010 [25] | March 2008 and August 2009. | Birth weight 2500–4000 g and aged 2–16 weeks | L. reuteri DSM 17938 | 108 colony-forming units in 5 drops, once a day, 30 minutes before the feed in the morning, for 21 days | Placebo | A reduction of average crying time to less than 3 hours a day on day 21. |
50 exclusively breastfed infants were recruited from general pediatricians and outpatients at the Department of Pediatrics, University of Turin (Regina Margherita Children Hospital) | ||||||
A Randomized, Double-Blind, Placebo-Controlled Trial | ||||||
Szajewska/2013 [26] | January 2010 and December 2011. | Full term infants aged <5 months | L. reuteri DSM 17938 | 108 colony-forming units in 5 drops, orally, once a day, for 21 days | Placebo | The percentage of children achieving a reduction in the daily average crying time more than 50% and the duration of crying at 7, 14, 21, and 28 days after randomization. |
80 exclusively or predominantly (>50%) breastfed infants | ||||||
Family primary care practice in Warsaw, Poland | ||||||
A Randomized, Double-Blind, Placebo-Controlled Trial |