To date, we’ve conducted in-house trials where we fed 30-40g of fructan to ourselves and brave friends and family members. We conducted these experiments in the most statistically rigorous way and obtained convincing data on the efficacy of FODZYME when it comes to flatulence and diarrhea events.
Once we gained conviction on FODZYME’s formulation, we conducted a series of in-vitro experiments to gain more insight into FODZYME’s mechanism of action. To do so, we tested FODZYME in SHIME, a scientifically validated model of the human gut that simulates all essential biological processes in the human digestive tract. In these experiments, a dose of FODZYME was added together with 3g of fructan to see how effectively FODZYME’s fructan hydrolase breaks it down. We assessed lactase and alpha-galactosidase in a separate control arm to verify the specificity of our fructan hydrolase in fructan hydrolysis. We discovered that fructan was rapidly broken into simple fructose, with ~90% of the fructan degraded within 30 minutes. Thus confirming that our enzymes are resilient to post-prandial stomach conditions (i.e., acidity and protease activity). The study also showed that 70% of fructose was absorbed during the simulated small intestinal transit, thus reducing gas. We also found that short-chain fatty acid (SCFA) production was reduced but not depleted. This means that FODZYME’s enzymatic approach may be more favorable to overall colonic health than avoiding FODMAPs altogether.
We certainly have a long way to go in our clinical journey and are encouraged by the overwhelmingly positive anecdotal reports of FODZYME’s efficacy. While we work to generate more rigorous clinical data, we see FODZYME as a low-risk intervention with a high potential for benefit in the right patients.