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
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.
This double-blind, randomised study aimed to evaluate the effect of probiotic supplementation with Lactobacillus reuteri DSM 17938 (1×10^8 CFU per day) or placebo for 30 days, on regurgitation and gastric emptying in 42 formula-fed infants with functional gastroesophageal reflux.
The infants were on average 40 days old at study entry and had at least 4 regurgitation episodes per day in the week prior to the study. 34 infants completed the study; 19 in the probiotic group and 15 in the placebo group.
At the end of the study the newborns receiving Lactobacillus reuteri had a significant decrease in regurgitation (1 episode/day vs. 4 episodes/day; p=0.001), a significant increase in the change in gastric emptying rate compared to baseline (+11.7% vs. +8.4%; p=0.01), and a significantly reduced fasting antral area during the last 7 days of the study (reduction of 3.0 vs. 4.0; p=0.01), compared to those receiving placebo.
The significant reduction in the number of regurgitation episodes and improved gastric emptying patterns in infants receiving Lactobacillus reuteri suggest that this has a useful role in improving gut function in formula-fed infants.
This is a double blind, placebo-controlled pilot study investigating the effects of daily probiotic supplementation on feeding tolerance and gastrointestinal motility in healthy, formula-fed preterm infants.
Thirty infants with a mean gestational age of 34 weeks and mean birth weight of 1,890 gram were enrolled. Ten infants were exclusively breast-fed, and 20 were randomly assigned to receive either 1×10^8 CFU (Colony Forming Units) of Lactobacillus reuteri ATCC 55730/day or placebo for 30 days, and a standard infant formula.
Fig. 1 In each patient the gastric emptying rate was expressed as percent reduction in antral cross sectional area from time 0 to 120 minutes after the meal ingestion.
At the end of the study period gastric emptying rate was significantly improved in formula-fed infants receiving Lactobacillus reuteri compared to the placebo group (P<0.001), as measured by ultrasonography.
Daily regurgitations were reduced to 2.1 vs. 4.2 (P<0.01) and daily bowel evacuations were increased to 3.7 vs. 2.1 (P<0.05), respectively. Daily crying time was significantly decreased to 32 minutes in the Lactobacillus reuteri group vs. 88 minutes/day in the placebo group (P<0.01). The breast-fed infants’ mean daily crying time was 66 minutes. Weight gain per day was similar in the three groups and there were no adverse events.
Conclusion: Daily Lactobacillus reuteri supplementation to preterm formula-fed newborns improved tolerance to the formula. This was shown as a significant decrease in regurgitations and mean daily crying time, and an increased number of stools compared to those given placebo. Gastric emptying was also improved.