The study showed that infants supplemented with L. reuteri Protectis reduced the frequency of regurgitation by 80 %. Gastric emptying was significantly accelerated compared to placebo.
These results confirm those from our earlier study in preterm infants and therefore strengthen the evidence for positive effects of L. reuteri in infants with uncomplicated regurgitation, says Dr Flavia Indrio, Department of Paediatrics, University of Bari, Bari, Italy.
In this double-blind, placebo-controlled, parallel-group trial 42 formula-fed infants younger than four months with regurgitation were consecutively randomised to supplementation with either L. reuteri Protectis (DSM 17938, 1x10 to the power of 8 CFU) or placebo once daily for 30 days. In the group supplemented with L. reuteri Protectis episodes per day of regurgitation were reduced by 80 % compared to 33 % in the placebo group. During the last week of supplementation episodes of regurgitation were 75 % lower in the probiotic group compared to placebo (p<0.001).
- Uncomplicated regurgitation is common among infants and we are convinced that these exciting results with L. reuteri will have an impact on future handling of infants with persistent regurgitation, says Dr Indrio. - The new and positive data adds to the bulk of clinical evidence with L. reuteri Protectis on gut disorders in infants and further strengthens BioGaia's position on the infant market, says Peter Rothschild, President, BioGaia.
Facts on regurgitation
Regurgitation is defined as the passage of refluxed gastric content into the throat whilst vomiting is defined as expulsion of refluxed gastric content from the mouth. The frequency of regurgitation varies with age, with infants up to the first month being more frequently affected.