This randomised, placebo-controlled, double-blind trial was performed to investigate the effectiveness of L. reuteri DSM 17938 (L. reuteri Protectis) for the treatment of infantile colic in breastfed infants, as compared to placebo.
42 colicky infants, exclusively or predominantly breastfed, were randomly assigned to receive five drops (10^8 CFU) per day of L. reuteri Protectis (n=21) or placebo (n=21) for 28 days.
Primary outcome was measured as rate of responders at day 28 (defined as reduction of daily crying time by ≥ 50% compared to baseline)
Secondary outcomes was measured as duration of mean daily crying time at day 7, 14, 21 and 28, parents satisfaction with treatment and reduction in maternal depression
No study-related adverse events were reported
The 5th study to prove significant effect by L. reuteri Protectis in breastfed or predominantly breastfed colicky infants. The first Chinese study confirming the findings of three European ones and one in North America. Already after one week, reduction in daily crying time can be expected. Prompt treatment with L. reuteri Protectis can also improve parental satisfaction and family functioning
Treatment success was achieved in all infants that received
L. reuteri Protectis but only in barely 16% of the placebo group
Significantly less crying from day 7 and onwards versus placebo
100% parental satisfaction after 3 weeks of probiotic
treatment but barely 16% in the placebo group
Significantly improved maternal depression scores throughout
the study (Red dotted line: Score 9 or greater = possible depression)