BioGaia

Regulatory Filings • Dec 8, 2010

Press Release 8th December 2010

New study published:

Lactobacillus reuteri Protectis reduced regurgitation and improved stomach emptying in infants

The study showed that infants supplemented with L. reuteri Protectis significantly reduced the frequency of regurgitation by 80 %. Gastric emptying was also 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, 1x108 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.

The study was published online ahead of print 26th November 2010 in European Journal of Clinical Investigation, DOI: 10.1111/j.1365-2362.2010.02425.x.

For additional information contact:

Flavia Indrio, Doctor, Department of Paediatrics, University of Bari: +39 329 293 8421 Eamonn Connolly, Vice President Research, BioGaia: +46 8 555 293 00 Peter Rothschild, President, BioGaia: +46 8 555 293 00

BioGaia publishes this information in accordance with the Swedish Securities Markets Act. The information was published on December 8, 2010, at 09:00 AM CET.

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BioGaia is a biotechnology company that develops, markets and sells probiotic products with documented health benefits. The products are primarily based on the lactic acid bacterium Lactobacillus reuteri, which has probiotic, health-enhancing effects. The class B share of the Parent Company BioGaia AB is quoted on the Small Cap list of the NASDAQ OMX Nordic Exchange Stockholm. www.biogaia.com