Tackling PPI side-effects: Belgium sporebiotics start-up My Health to enter India and greater China markets this year
Speaking to NutraIngredients-Asia, CEO Raf Dybajlo, said that the expansion plan would focus on working with key opinion leaders, such as specialist doctors, in introducing the sporebiotics as an add-on to medical therapies.
Working with pharmacies and healthcare professionals is already the mode of operation for the company in the domestic Belgium market, as well as its other existing markets, including Germany and the Baltic states.
Its newly launched product, known as My Gastric, aims to tackle gut dysbiosis and side effects such as small intestinal bacterial overgrowth (SIBO) caused by the long-term use of proton pump inhibitor (PPI) medications.
Proton pump inhibitor medications include examples such as omeprazole, which is a medication prescribed to reduce gastric acid in patients suffering from indigestion and acid reflux etc.
Dybajlo noted that while such medications were important and beneficial, long term use for more than eight weeks could cause side effects that could worsen the condition.
“PPI medications could be used to reduce stomach acid, but it can cause shift in the microbiome, such as an overgrowth of the bacteria streptococcus in the small intestines and this could increase risk for gastroenteritis in the long term.
“We are not against the PPI medications, we need the medications, but if one were to need it in the long term, they can use it with our probiotics as an add-on therapy [to modulate the microbiome dysbiosis],” Dybajlo said.
Clinical trial
The company has conducted its first human clinical trial with Universitaire Ziekenhuizen Leuven in Belgium to assess the benefits of sporebiotics when used with PPI medications.
The trial assesses sporebiotics from the Bacillus genus, which Dybajlo pointed out was a bacterium that forms spores naturally.
The bacterium is resistant to heat and pH changes, allowing it to survive stomach acid and reach the intestines, in turn modulating the gut microbiome.
Other benefits including a longer shelf life and lower CFU of bacteria required to be added into the product.
The sporebiotics assessed in the clinical trial were Bacillus coagulans MY01 and Bacillus subtilis MY02.
During the trial, the researchers assessed if the supplementation of one capsule of the probiotics twice daily and PPI medications could reduce upper gastrointestinal symptoms as compared to subjects who only took PPI medications.
While the trial results are not yet published, Dybajlo revealed the results were good and hoped to share them in a publication soon.
“We are a strong believer of looking at the small intestines when treating stomach problems. We believe that stomach problems do not only originate from the stomach but inflammation in the small intestines can be a cause as well,” Dybajlo said.
Aside from sporebiotics, the company also incorporates botanicals into its formulation.
In the case of My Gastric, 100mg of ginger root extract (with 20 per cent gingerols), acacia fiber, and 150mg of vegetable enzymes are added into the formulation containing 2.5bn CFU of Bacillus coagulans MY01 and 2.5 bn of Bacillus subtilis MY02.
Strategies
Aside from identifying healthcare practitioners as its distribution partners, the company plans to enter the new India and greater China markets with its flagship product My Gastric.
“My Gastric is our most important and flagship product. We plan to start any distribution negotiation with it,” Dybajlo said, adding that the company had spent about 3.5 years on the R&D.
Other than My Gastric, the company also plans to introduce its My Flora comfort and My Flora fast probiotics. The range is for supporting normal bowel function. They contain 1.25 bn CFU of Bacillus coagulans, 1.25 bn CFU of Bacillus subtilis, 150mg of artichoke extract, and acacia fiber.
The company also has sporebiotics products for the immunity, UTI, menopause, and muscles, and nervous system, fatigue, stress, and sleep.
In India, it has partnered with responsible nutrition and market-access platform Nutrify Today.