Writing in the BMJ, the US-based firm concludes that the novel 5-strain probiotic formulation, WBF-011, significantly improves A1C and blood glucose spikes in people with T2D.
The actions of Clostridium beijerinckii WB-STR-0005 and Clostridium butyricum WB-STR-0006 suggests the formulation can provide dietary management of blood glucose control through the gut microbiome.
Other probiotics contained in the blend include Akkermansia muciniphila WB-STR-0001, Eubacterium hallii WB-STR-0008 and Bifidobacterium infantis 100 as well as a prebiotic.
‘Promising new tool’
“The research demonstrates that the administration of microbial species, selected for their known beneficial functions in the microbiome, is a promising new tool that augments the traditional dietary measures for improving glucose control in type 2 diabetes,” says Dr Orville Kolterman, senior study author and chief medical officer at Pendulum Therapeutics.
“It is well established that improved glucose control reduces the risk for the devastating long-term complications of diabetes."
According to Pendulum, the blend remains the first and only clinically evidenced medical probiotic designed for the dietary management of T2D.
Previous trials testing the efficacy of probiotics have used commercially available species that are not known to be absent or decreased in T2D.
T2D is linked to gut microbiome abnormalities, particularly decreases Akkermansia muciniphila numbers and microbes involved in the conversion of dietary fibre to butyrate and other short-chain fatty acids.
An increase in the abundance of butyrate producers and Akkermansia muciniphila induced by metformin treatment has been proposed as a supporting mechanism for the efficacy of this critical antidiabetic drug.
The multi-site, double-blinded, placebo-controlled, randomised, nutrition trial enrolled 76 subjects with T2D in which 26, 27, and 23 individuals were randomly assigned to receive placebo, WBF-010 (containing Clostridium beijerinckii WB-STR-0005 and Clostridium butyricum WB-STR-0006 and Bifidobacterium infantis 100), and WBF-011, respectively.
The subjects, who controlled their condition via diet and exercise alone or in combination with metformin, were asked to stick to the two times a day regimen of placebo, WBF-010 or WBF-011 for 12 weeks.
Results revealed a statistically significant improvement in A1C and blood glucose control. At 12 weeks, the data showed that those who received Pendulum's formulation experienced a 33% decrease in post-meal blood glucose spikes (AUC) and a 0.6% decrease in hemoglobin A1C relative to placebo.
Further findings revealed the product to be well-tolerated with no safety issues were observed in the study.
“The link between health, metabolism and the gut microbiome is generating a high level of interest and scientific research," says Dr Carol Wysham, clinical professor of medicine, clinical endocrinologist and president elect of the Endocrine Society.
"We are only just scratching the surface regarding microbiome-based interventions that have the ability to improve health. These interventions must pose no safety risks and be backed by solid scientific research.”
As Pendulum acknowledges the small sample size, imbalance created by the higher discontinuance rate in the placebo group, and participants with relatively short disease duration are limitations of the study.
The research also did not measure a dose-response relationship, the optimal duration of administration, or the durability of effect.
While Glucagon-Like Peptide 1 (GLP-1) levels were not directly measured, plasma insulin concentrations during meal tolerance tests was measured as a marker of GLP-1 action
The researchers also admit that while the WBF-011 group showed a possible trend towards enhanced insulin secretion, the difference was not statistically significant.
Source: BMJ Open Diabetes Research & Care
Published online: doi.org/10.1136/bmjdrc-2020-001319
“Pendulum Therapeutics Announces Publication Of Clinical Data For First-Ever Medical Probiotic That Provides The Dietary Management Of Healthy A1C And Blood Glucose Levels.”
Authors: Fanny Perraudeau et al