Probiotics developers push boundaries of product categories

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Probiotic supplements are widely promoted as a general way to support gut microbiome and promote health, but what about condition-specific probiotics?

A new category called ‘medical probiotics’ is emerging, said Colleen Cutcliffe, Ph.D., CEO and co-founder of Pendulum Therapeutics. "Medical probiotics are a new category of probiotics that deliver clinical efficacy for the management of a specific disease or condition with targeted and novel probiotic strains.”

A new publication in the Journal of Family Practice discusses the latest evidence on using probiotics for several  specific health conditions, with the guidance of a physician. 

"Probiotics are not the same as drugs, but it's still important for physicians to recommend them in an evidence-based manner," stated lead author Dr. Daniel J. Merenstein, Professor of Family Medicine at Georgetown University Medical Center in Washington, DC.

Probiotics for diabetes

Type 2 diabetes affects nearly 30 million Americans, and impacts many parts of the body, especially the digestive system. Research suggests the gut microbiome is a major environmental determinant of obesity and type 2 diabetes (T2D), and gut dysbiosis plays a major role in the development of chronic low-grade inflammation and in the development of insulin resistance. 

As scientists learn more about the link between the gut and diabetes, more supplements specific to diabetes are being introduced. 

Pendulum Therapeutics, a microbiome company, recently announced the launch of Pendulum Glucose Control. The company said it is the first and only medical probiotic clinically shown to lower A1C and blood sugar spikes. 

Pendulum conducted pre-clinical and clinical assessments of the safety and metabolic effects of Pendulum Glucose Control. In a 12-week randomized, double-blinded, placebo-controlled nutritional study, the probiotic was shown to lower A1C by 0.6% and blood sugar spikes by 3% compared to placebo in people with type 2 diabetes (Kolterman et al. Diabetes, 2019; Vol. 68 (Supplement 1), doi: 10.2337/db19-758-P). The study states that the product is a medical food.

"We're taking a new approach to managing type 2 diabetes through the gut microbiome with Pendulum Glucose Control," said Cutcliffe. “Our patented formulation contains a novel and unique blend of a prebiotic and strains of beneficial probiotic bacteria that can't be found in any other probiotic on the market. And unlike 'off-the-shelf' probiotics with general 'gut health' claims, our medical probiotic has been clinically tested and shown to deliver meaningful benefits for managing blood sugar levels."

For people with type 2 diabetes, a key challenge is difficulty in metabolizing fiber in order to manage blood glucose. The company said their product contains targeted strains of beneficial bacteria that help restore disrupted gut function in people with type 2 diabetes. 

Pendulum employed DNA sequencing to identify these novel strains (Clostridium beijerinckii WB-STR-0005, Clostridium butyricum WB-STR-0006, Akkermansia muciniphila WB-STR-0001, Eubacterium hallii WB-STR-0008, Bifidobacterium infantis 100) to help metabolize fiber and produce butyrate, a short-chain fatty acid which plays a big role in the body's natural ability to signal insulin production and stabilize blood glucose.  

"With the introduction of Pendulum Glucose Control, Pendulum is revolutionizing the way we approach the dietary management of type 2 diabetes," said Davida F. Kruger, MSN, APN-BC, BC-ADM, certified nurse practitioner in diabetes in the Division of Endocrinology, Diabetes and Bone Metabolism within the Henry Ford Health System. "Pendulum Glucose Control plays a unique role in restoring lost functionality in the gut microbiome and maximizing the benefit of dietary fiber to help manage healthy blood sugar levels."

Pendulum Glucose Control is currently available online for $165 per month and comes with a money-back guarantee.  The company's products are branded as 'medical probiotics' as opposed to 'dietary supplements' on the front label.