Questions & Answers on Francavilla and Bosque Helicobacter pylori studies November 2011

 

 

BioGaia Gastrus has now been tested for the first time in two independent, randomised, double blind, placebo-controlled clinical trials. These have been conducted to determine the effects of L. reuteri Gastrus on the control of Hp infection patients with mild symptoms, one in Bari in Italy and one in Monterrey in Mexico.

 

Both studies had the same inclusion criteria and study design: 100 patients were enrolled, 50 of those received L. reuteri Gastrus alone for 28 days and 50 received placebo. Thereafter both groups received triple therapy, in combination with Gastrus or placebo, for seven days. For the follow-up period of 60 days the groups again received only Gastrus or placebo.

 

Main objectives of the studies were reduction of infection load, reduction of symptoms and reduction of inflammation.

 

The Italian study demonstrated a significant reduction in Helicobacter pylori load and symptoms in the pre-eradication period when BioGaia Gastrus was given alone. Moreover, during this period three of 50 subjects in the Gastrus group compared to one of 50 in the placebo group lost their infection completely. Eradication rates under triple therapy were unchanged by Gastrus use, but symptoms were again significantly improved during the therapy in the probiotic group compared to those receiving placebo.

 

In the Mexican study no significant reductions in Helicobacter pylori load or in symptoms were observed in the pre-eradication period with Gastrus. However, as in the Italian study, three of 50 subjects in the Gastrus group lost their infection completely when given Gastrus alone, compared to none in the placebo group. Histopathological analysis of the gastric mucosa showed significant benefit of both BioGaia Gastrus and placebo supplementation, but there were no significant changes in mucosal cytokine patterns after supplementation. Eradication rate was unchanged by probiotic supplementation, as were symptom scores during eradication. The investigators are now analysing why the results differ in the two studies and we hope to have possible explanations soon.

 

The investigators are now working on their manuscripts to be submitted for publication in reputable scientific journals later this year or in the beginning of next year.

 

 

BioGaia has decided to launch Gastrus in a few markets next year, probably Slovakia, Italy and Spain. BioGaia’s “official launch” will be at the UEGW in Amsterdam in October 2012.

 

Two studies are on going, one in Slovakia and one in Bulgaria. In these studies BioGaia Gastrus is tested in combination with PPI (omeprazole) only. The results of these studies are expected during the first half of 2012.

 

BioGaia is planning more studies on patients suffering from Helicobacter pylori infections with the aim to establish a wider platform within this area.