At the 3rd Probiotics, Prebiotics New Foods Congress in Rome September 4-6 2005, Dr Ruggiero Francavilla and colleagues from the University of Bari, Italy presented a study on 20 adults infected by H. pylori with symptoms who were blindly randomised to receive either Reuteri or placebo for 28 days. They found a significant decrease in the level of H. pylori infection coupled to a significant improvement in gastrointestinal symptoms (abdominal pain, reflux, indigestion, diarrhoea and constipation) with Reuteri compared to placebo. They concluded that there might be a role for Reuteri supplements in the control of dyspeptic symptoms in H. pylori infected adults.
These findings confirm earlier data obtained in a clinical trial by Professor Shin´ichi Takahashi at Kyorin University School of Medicine, Tokyo, Japan where a similar reduction on H-pylori levels in non-symptomatic H. pylori-infected subjects was observed. This data was presented at the 91st Annual Meeting of Japanese Society of Gastroenterology in Japan in April.
Dr Francavilla went on to study H. pylori-infected dyspeptic children who required eradication (antibiotic) therapy. Twenty-five H. pylori-positive children were treated with 10-day eradication therapy and were blindly randomised to receive either Reuteri or placebo for 20 days staring from the first day of treatment. The severity of side effects was measured using a validated scoring system (GSRS score). At entry, children in both groups had similar GSRS scores but during eradication therapy and follow-up, the Reuteri-supplemented children had significantly improved gastro-intestinal health compared to the placebo group. The investigators concluded that Reuteri given during and after H. pylori eradication therapy significantly reduces the frequency and intensity of antibiotic associated side effects.
Professor Alfredo Saggioro from Umberto I Hospital in Venice presented a new study at the 11th National Congress of Digestive Disease in March where 30 H. pylori-infected dyspeptic patients were randomly assigned to take either the proton pump inhibitor omeprazole together with Reuteri or omeprazole with placebo for 4 weeks. Of the 15 patients receiving omeprazole with Reuteri, 9 (60%) were found to have lost their H. pylori infection, whilst none of the 15 in the omeprazole group had lost their infection. It was concluded that Reuteri in combination with omeprazole may thus have significant clinical value.
These data will be used in the marketing of Reuteri products to the health care sector and we look forward to their full publication, which will further strengthen BioGaia´s study portfolio. The company is also contemplating whether or not to develop products specifically directed to H. pylori-infected people and, if there is interest from pharmaceutical companies, to combine a Reuteri product with a proton pump inhibitor as an adjunct in H. pylori infection control.