This multicentre, double-blind, placebo-controlled study investigated whether Lactobacillus reuteri DSM 17938 (L. reuteri Protectis) during the first three months could reduce the onset of colic, constipation and regurgitation in term newborns and thereby reduce the socio-economic impact of these conditions. 589 healthy infants were randomised to supplementation with either Lactobacillus reuteri Protectis drops (1×10^8 CFU) or placebo once daily for 90 days. 468 infants completed the study.

53% less of inconsolable crying with L. reuteri Protectis compared to placebo at one month

After one month of intervention the infants in the Lactobacillus reuteri Protectis group cried less than half as long per day as the infants given placebo, 45 minutes compared to 96 minutes (p<0.01). The significant difference between the groups persisted to the end of the 3-month intervention.

30% more daily evacuations with L. reuteri Protectis compared to placebo at one month

The infants in the Lactobacillus reuteri Protectis group also had an improved gut motility, leading to significantly more daily evacuations and less regurgitation compared to the infants in the placebo group. There were no adverse events reported.

37% fewer daily regurgitations with L. reuteri Protectis compared to placebo at three months

The study also evaluated the cost/benefit of the supplementation. The assessment model used did not take into account indirect costs such as those related to parental anxiety and stress. Calculating the direct costs only, the investigators concluded that the use of Lactobacillus reuteri Protectis saved each family 88 euro. In addition to this the community saved 104 euro per child.

€88 saved in direct costs for each family using Lactobacillus reuteri Protectis compared to placebo

Conclusions:
Prophylactic use of Lactobacillus reuteri Protectis during the first 3 months of life reduced the onset of functional gastrointestinal disorders and reduced private and public costs for the management of this condition.

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