This randomised, controlled, single-blinded, multi-centre study was performed to evaluate the efficacy of L. reuteri DSM 17938 in reducing parental discomfort due to infantile colic in a population of otherwise healthy infants.

105 infants aged less than 10 days were randomly assigned to receive five drops per day (10^8 CFU) of L. reuteri Protectis with vitamin D (n=51), or vitamin D only (n=54), for three months.

Primary endpoint was measured as use of pain relieving agents. Secondary endpoints was measured as percentage of infants that switched from an exclusive breastfeeding to partial or exclusive formula feeding and number of calls to the paediatricians and number of visits at paediatricians’ ambulatories due to infantile colic

The results showed:
1) Significantly less use of pain relieving agents in infants supplemented with L. reuteri Protectis compared to control group

• 75% less use of simethicone
• 96% less use of cimetropium bromide

2) Fewer paediatric consultations in the L. reuteri Protectis group versus control

• 47% fewer visits to paediatricians
• 40% fewer phone calls to paediatricians

3) 63% less use of infant formula in the L. reuteri Protectis group in the first three months

Conclusions
L. reuteri Protectis reduced parental distress and was effective in the prevention of colic in healthy infants:
• Less need of pain relieving agents
• Lower number of paediatric consultations
• Less use of infant formula

This study adds evidence to the previous study with L. reuteri Protectis and the beneficial effects in the prevention of infantile colic