Project Summary/Abstract
This SBIR Phase II project follows up on a highly successful Phase I project, where we
initiated the development of a new and innovative probiotic strain designed for the prevention of
kidney stones. This novel probiotic strain has an optimized ability to biodegrade oxalic acid.
About 75% of kidney stones consist of calcium oxalate (CaOx), and the root cause of CaOx
stones is an excessive urinary oxalate levels.
There are few tools available to prevent CaOx stones, and none address this root cause.
Current kidney stone prevention approaches rely mostly on dietary modifications, an lean
heavily increasing fluid intake. However, adherence rates are commonly below 50%. Avoiding
oxalate-rich foods is also recommended to limit calcium oxalate stone growth, but again,
adherence rates are low, and a low oxalate diet is difficult to follow. There are few tools
available beyond dietary adjustments: Alkalinizing agents such as potassium citrate can reduce
stone recurrence, but can be surprisingly costly and often cause GI distress. Thiazide diuretics
increase urinary volume and reduce urinary supersaturation, but they come with frequent,
potentially life-threatening adverse effects such as hypokalemia.
In contrast, our probiotic is a safe, cost-effective, innovative and promising strategy for
eliminating oxalic acid before it can be absorbed in the small intestine, with the goal being a
reduction in oxalic acid levels in urine.
The main impact of this project will be the development of an accessible, affordable and
safe tool that does not have side effects seen with available treatment options. The proposed
SBIR Phase II project is designed to overcome remaining steps that need to be completed
before commercialization of our proposed innovation. Through Phase II Aims 1-4 we will
complete critical activities, including scale-up, confirmation of efficacy in a rat model of kidney
stones, and demonstrating safety and tolerability in order to obtain Generally Recognized As
Safe (GRAS) affirmation.
The severe physical pain and suffering, the serious adverse psychological distress, and the
very serious adverse economic impact caused by kidney stones underscores the need to
explore new and innovative prevention approaches. Anticipated rises in the prevalence of
kidney stones and hyperoxaluria, along with the limitations of current treatments strongly
emphasize the societal demand for a hyperoxaluria treatment that is not only accessible and
affordable but also safe.