The research presented on this page is provided for scientific information and does not constitute a health claim.
Anaerobutyricum soehngenii has been evaluated in four completed human clinical studies, all published in peer-reviewed journals. Together, these studies provide evidence across metabolic syndrome, type 2 diabetes and adults at risk of developing type 2 diabetes.
A. soehngenii was safe and well tolerated across the clinical programme, with no serious treatment-related adverse events reported. A separate toxicological evaluation of Anaerobutyricum soehngenii CH106 found no adverse effects attributable to the strain.
In a phase I/II dose-escalation study, greater intestinal colonisation by A. soehngenii was associated with significantly improved peripheral insulin sensitivity after four weeks of treatment.
A randomised, double-blind, placebo-controlled study in adults with type 2 diabetes receiving metformin found that 14 days of oral A. soehngenii significantly reduced glycaemic variability and improved overall glucose control, alongside a reduction in mean arterial blood pressure.
In a three-month randomised, double-blind, placebo-controlled study in 98 adults with prediabetes and insulin resistance, CH106 significantly reduced glycaemic variability and improved overall glycaemic control. The study also reported reductions in HbA1c and diastolic blood pressure.
A randomised double-blind placebo-controlled cross-over study points towards A. soehngenii acting through host metabolic pathways rather than broadly reshaping the gut microbiome. Direct duodenal A. soehngenii administration stimulated endogenous GLP-1 secretion and improved glycaemic control, while mechanistic findings also point to changes in bile acid metabolism and duodenal gene expression.
Published safety package · Positive EFSA safety opinion · FDA-notified GRAS (GRN 1065)
Caelus’s clinical evidence is supported by a documented safety package for CH106, enabling regulatory progress in both Europe and the United States.
The published clinical evidence provides partners with a strong scientific foundation on which further product-specific development can build.
