Pylopass™ is a proprietary strain of Lactobacillus reuteri which specifically coaggregates with Helicobacter pylori in the stomach to reduce the
bacterial load. Pylopass™ is comprised of spray-dried L. reuteri cells and is stable in a wide
range of applications for the end consumer
PYLOPASS™ A UNIQUE
MODE OF ACTION
The Pylopass™ strain of L. reuteri was identified after a detailed, multi-year screening process. It
was selected as a highly specific binding antagonist to H. pylori among more than
700 wild-type strains of Lactobacillus species of the ORGANOBALANCE culture collection of several thousand
food grade strains. Through a specific mechanism, Pylopass™ forms coaggregates with
H. pylorito decrease the overall load in the stomach, thereby decreasing the risk of developing
gastritis and peptic ulcer disease.
The surface structures on Pylopass™ contain adhesion
molecules that recognize and adhere to surface
structures on H. pylori.
After coaggregation in
the stomach has occurred, the entire coaggregate is excreted from the body through the
digestive tract. Pylopass™ specifically binds to
H. pylori and does not alter the microflora of
Advantages over probiotics
Product stability: Unlike probiotics, Pylopass™
consists of spray-dried cells which can withstand
environmental fluctuations. For shipment and
storage, Pylopass™ does not require temperature controls.
Specificity for H. pylori: While probiotics cater
to general gut health, Pylopass™ specifically
binds H. pylori in the stomach. Furthermore,
Pylopass™ does not bind or disturb the normal
gut microbial balance.
Stability in gastric conditions:
In contrast to
probiotics, Pylopass™ employs a mechanism
which is not dependent on survival in the gastric
environment. Probiotics can be beneficial
because they may replace harmful bacteria in
the gastrointestinal tract. However it is uncertain whether such living probiotic strains can
withstand the acidic environment in the
stomach. This concern is not a challenge for
Pylopass™ as the coaggregation depends only
on the binding of surface structures between
Pylopass™ and H. pylori.
Advantages over antibiotics
Triple and even quadruple
antibiotic therapies are non-specific and have
numerous side effects such as diarrhea and taste
disturbances. On the contrary, there are no side
effects related to Pylopass™ ingestion or administration.
No risk of antibiotic resistance: Research shows
that the number of antibiotic resistant strains
of H. pyloriis increasing globally. In Asia, an
estimated 37% of cases are resistant to metronidazole and 65% of cases are resistant to amoxicillin in Africa4. Ramakrishna has argued
against the case of eradication, as treatment
with antibiotics may prove ineffective, due to
high frequencies of antibiotic resistant strains5.
Pylopass™ offers an alternative management
modality that does not contribute to the problem of antibiotic resistance.
PYLOPASS™ IN HUMANS
The UBT Test
Human clinical trials have been able to show
the effect of Pylopass™ supplementation on
Helicobacter pylori load. The study by Mehling
and Busjahn used a crossover study design with
a two-week placebo period followed by a two-week supplementation period with Pylopass™6.
Study participants took Pylopass™ with their
morning and evening meals with a daily dose
of 200 mg/day. The effect of Pylopass™ was
measured via 13C urea breath test (UBT). The
UBT is a rapid non-invasive diagnostic method
of testing for H. pylori infection based upon the
ability of H. pylori to convert urea to ammonia
and carbon dioxide by urease activity.
The statistically significant effect of
Pylopass™ after the two-week supplementation
period is depicted.
In another single-blinded and placebo control led study Holz et al.7
determined the impact of
two-week oral intake of Pylopass™ on H. pylori
load, applying a daily dose of 2 x 1010
lyophilized Lactobacillus reutericells (equivalent to 200 mg Pylopass™). This intervention led
to a significant decrease in H. pyloriload in healthy subjects with detectable H. pylori
infection in a general population sample.
The reduction of H. pylori was detected by UBT.
Treatment by placebo did not result in a significant change in 13
C UBT (∆ placebo -0.6 ± 5.3),
whereas verum treatment significantly reduced 13
C UBT values (∆ verum -4.9 ± 7.8, p = 0.026 vs.
1 Go MF (2002) Review article: Natural history and
epidemiology of Helicobacter pylori infection.
Aliment Pharmacol Ther 16: 3–15
2 Fock KM & Ang TL (2009) Epidemiology of
Helicobacter pylori infection and gastric cancer in
Asia. J Gastroen Hepatol 25: 479– 486
3 Malfertheiner P et al. (2012) Management of
Helicobacter pylori infection – the Maastricht IV/
Florence consensus report. Gut 61: 646–664
4 De Francesco V et al. (2010) Worldwide H. pylori antibiotic resistance: a systematic review. J Gastrointestin
Liver Dis 19: 409– 414
5 Ramakrishna BS (2006) Helicobacter pylori infection
in India: the case against eradication. Indian J Gastroenterology 25: 25–28
6 Mehling H & Busjahn A. (2013) Non-viable
Lactobacillus reuteri DSMZ 17648 (Pylopass™) as
a new approach to Helicobacter pylori control.
Nutrients 5: 3062–3073
7 Holz C et al. (2014) Significant reduction in
Helicobacter pylori load in humans with non-viable
Lactobacillus reuteri DSM17648: A pilot study.
Probiotics & Antimicro. Prot. 7: 91–100
PYLOPASS™QUALITY AND SAFETY
Quality and Safety at a glance:
- Qualified Presumption of Safety (QPS) status
in the EU
- GRAS status in the US
- No antibiotic resistance
- Manufactured according to HACCP guidelines
- Halal certified
- Vegetarian, non-GMO and solvent free
Microbial fermentation is a one of ORGANOBALANCE’s core competencies. Pylopass™ is
produced via fermentation in a controlled production facility.
Because the coaggregation
activity is of utmost importance, Pylopass™ is
produced by standardization to coaggregation
levels. This differs from a traditional probiotic,
which is fermented to obtain a certain cell
This means that Pylopass™ products have
been fermented to their peak aggregation abilities. After fermentation, the cells are harvested,
suspended in a matrix and spray-dried to obtain
a free flowing powder.
As a raw ingredient manufacturer, we not only actively promote our ingredients on a business-to-business level, but we also support our customers in many ways.
Our regulatory experts collaborate with authorities and organizations globally to work towards a regulatory situation that is in favor of Pylopass™ products. We have years of experience with regulatory dossiers and a track record of successful regulatory initiatives.
Due to the stable nature of Pylopass™, it does not need to be refrigerated and can be used as a dietary supplement, in powdered beverages and in fermented dairy products. Based on human studies, the recommended daily dose of Pylopass™ is 200 mg, which can be divided into several servings per day. One gram of Pylopass™ contains approximately 100 billion Lactobacillus reuteri cells.
ORGANOBALANCE collaborates with universities and research centers around the world to strengthen the scientific backing of Pylopass™. We maintain a database of published literature which is used by our technical experts to provide tailor-made, well researched answers on technical questions.
This website is an overview for professionals of published scientific information on Pylopass™ and published scientific information on clinical and nutritional trials with Pylopass™. No claims are made herein for any particular consumer product, and any use of these statements is the sole responsibility of the user based on his / her independent evaluation. The republication of the statements made herein is prohibited. It is always important to ensure that final communications to the consumer on food and food supplement products containing Pylopass™ comply with the applicable regulations in the regions / countries where the products are marketed.
The recommended use for Pylopass™ is as a nutrient or dietary supplement. The intended use of products containing Pylopass™ may be subject to different laws and regulations. The statements on this website have not been evaluated by the U.S. Food and Drug Administration. Pylopass™ is not intended for use to diagnose, treat, cure or prevent any disease. The information contained herein is believed to be correct and corresponds to the latest state of scientific and technical knowledge. However, no warranty is made, either expressed or implied, regarding its accuracy or the results to be obtained from the use of such information and no warranty is expressed or implied concerning the use of these products. The buyer assumes all risks of use and / or handling. No statement is intended or should be construed as a recommendation to infringe any existing patent.