A Single-blinded, Placebo Controlled, Crossover Study of Pylopass Versus Placebo in Subjects Who Are Helicobacter Pylori Carriers and With Mild Indigestion

Helicobator pylori (H. pylori) is a gram negative, spiral shaped bacteria which colonizes in the gastric mucosa. An estimated 50 percent of the world's population is infected with H. pylori.

H. pylori infection does not necessarily result in clinically relevant symptoms. Ching and Wong report that most cases of H. pylori are asymptomatic . Moreover, Kusters et al states that infection with H. pylori "is not a disease in itself but a condition that affects the relative risk of developing various clinical disorders of the upper gastrointestinal tract" (Kusters, 2006). Clinically relevant symptoms could include peptic ulcer, melena or secondary conditions such as iron deficiency anemia or vitamin B12 deficiency.

The most recent iteration of the Maastricht/Florence Consensus report outlines the diagnostic guidelines and treatment strategies for those with H. pylori (Malfertheiner 2012). Individuals with certain risk factors, such as a family history of gastric cancer, bleeding ulcer or with secondary disease such as iron deficiency anemia should undergo eradication therapy. For those with functional dyspepsia, the test and treat strategy has been recommended. However, there remains a lack of options for volunteers who are either asymptomatic or experience mild gastrointestinal symptoms who are not indicated for eradication therapy or to undergo the test and treat strategy.

There is evidence that probiotics can be beneficial for those with gastrointestinal diseases. A review by Ritchie and Romanuk succinctly summarizes this point by writing that "probiotics are generally beneficial in treatment and prevention of gastrointestinal diseases" (Ritchie 2012). In the context of H. pylori infection, probiotics are administered alongside conventional eradication treatment regimens to lessen the severity of side effects and improve tolerance. Francavilla et al has studied the impact of Lactobacillus reuteri on H. pylori load levels, as measured by urea breath test (UBT) values. The researchers found that a significant reduction in H. pylori load as evidenced by significantly decreased UBT values. They also found a decrease in symptom scores as measured by the Gastrointestinal Symptom Rating Scale (GSRS) (Francavilla 2008). Imase et al has also studied the impact of Lactobacillus reuteri supplementation in H. pylori infected individuals and found a suppressive effect from the L. reuteri tablets on UBT values (Imase 2007). These studies indicate that Lactobacillus reuteri exerts an effect on H. pylori by lowering the load.

There are many potential mechanisms by which probiotic strains, such as Lactobacillus reuteri, could exert a suppressive effect against H. pylori. One potential method is to stabilize or strengthen the gut mucosal barrier. Other mechanisms include sequestration of H. pylori, production of antimicrobial substances or through competitive binding to receptors in the gut (Garcia, 2009; Lesbros-Pantoflickova, 2007).