Results from two studies: BioGaia Gastrus in Helicobacter pylori infected patients
Results from two studies:
BioGaia Gastrus in Helicobacter pylori infected patients
BioGaia's new probiotic tablet BioGaia Gastrus has been tested in two
independent clinical trials in patients with Helicobacter pylori infection. In
one of them, performed in Bari, Italy, in 100 patients in with confirmed
Helicobacter pylori infection, BioGaia Gastrus supplementation led to a
significant reduction in infection load and symptoms.
- We have found that Gastrus was able to decrease Helicobacter pylori bacterial
load and to decrease the antibiotic associated side effects that are very
frequent and fastidious during the eradication therapy. Although the eradication
rates were similar in both treatment groups, we observed a spontaneous
eradication in three patients taking just Gastrus, says Dr Francavilla at the
Bari University Hospital.
The other study, performed in Mexico, did not show significant results.
Two independent, randomised, double blind, placebo-controlled clinical studies
have been performed to determine the effects of BioGaia Gastrus on the control
of Helicobacter pylori infection in patients with mild symptoms. The first trial
was performed in Bari, Italy, and the second in Monterrey, Mexico. Both trials
included 100 patients whereof 50 were given Gastrus before, during and after
standard triple therapy and 50 a placebo.
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.
- Our data shows that probiotics, although not indicated to eradicate
Helicobacter pylori, have the ability to increase the well being of a patient
before, during and maybe after the eradication regimen. Even when antibiotics
are not indicated or not tolerated by the patients, the use of a probiotic with
a well demonstrated anti Helicobacter pylori activity might be of great support
for the patient and the physician, says Dr Ruggiero Francavilla at Bari
University Hospital, Italy.
In the Mexican study, performed in 100 similar patients, 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.
- Our findings did not agree to those of the Bari study, although the protocols
were similar, which was surprising, and we are now analysing why the results
differ in the two studies. We did see spontaneous eradication of Helicobacter
pylori infection in 6% of the subjects given Gastrus alone, and this finding
alone creates great interest in the use of this probiotic in Helicobacter pylori
infected subjects, says Dr Francisco Bosques, University Hospital J.E. GonzÃ¡lez,
Autonomous University of Nuevo LeÃ³n, Monterrey, Mexico.
- Based on earlier documentation and the new, encouraging data, we have decided
to put BioGaia Gastrus on the market as we believe that Gastrus has a great role
to play in the control and treatment of Helicobacter pylori infections. A few
partners will launch already next year. There is more and more evidence that the
overuse of antibiotics is causing a series of problems and we believe that
Gastrus can help to reduce the use of antibiotics and also increase compliance
when consumed by these patients. With these new study results, earlier studies
and new on-going studies, we are creating a platform for Gastrus in the
treatment of Helicobacter pylori infections and as a compliment to the present
consensus treatment regimens, says Peter Rothschild, President at BioGaia.
There are already three published studies with Lactobacillus reuteri Protectis
in Helicobacter pylori patients showing reduction of infection load and
symptoms.1 Lactobacillus reuteri Protectis is one of two probiotic strains in
the new product BioGaia Gastrus. The other is Lactobacillus reuteri ATCC PTA
6475, a strain specifically chosen for its anti-inflammatory properties, which
is an important factor in the treatment of Helicobacter pylori-infection. Apart
from the newly completed trials Lactobacillus reuteri Gastrus is currently
tested in two independent trials and further trials are planned to start next
BioGaia is announcing these results today, as they will now be made available to
a wider circle for pre-launch and registration work. The researchers are
currently working on the manuscripts of the studies, which will be submitted for
publication in reputable scientific journals later this year or in the beginning
of next year.
For additional information please contact
Peter Rothschild, President, BioGaia: +46 8 555 293 00 or +46 70 830 65 40
Eamonn Connolly, Senior Vice President Research, BioGaia: +46 8 555 293 00
Ruggiero Francavilla, doctor, Bari University Hospital, Italy:
Fransisco Bosques, doctor, University Hospital, Monterrey, Mexico:
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1 Lionetti E et al. Aliment Pharmacol Ther. 2006;24:1461-8, Imase K et al.
Kansenshogaku Zasshi, 2007;81:387-93, Francavilla R et al. Helicobacter,
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