EFSA Issues Positive Opinion on Anaerobutyricum soehngenii

We are pleased to share that Anaerobutyricum soehngenii (A. soehngenii), a next-generation probiotic with significant potential in metabolic health, has reached an important milestone.

In 2025, Winclove Probiotics entered into a partnership with Caelus Health to support the path towards commercialisation of A. soehngenii and later added the strain to its portfolio. Today, Caelus announced that the European Food Safety Authority (EFSA) has issued a positive safety opinion for the strain.

This marks a major step forward in the European Novel Food approval process and brings commercial availability in Europe significantly closer.

More information
• Caelus Health Press Release
• EFSA Scientific Opinion

Why is this important?

A. soehngenii is a live, gut-native bacterium with distinctive butyrate-producing properties. Backed by a growing body of clinical evidence, the strain has attracted considerable interest in metabolic health and is widely recognised as one of the most promising developments in the microbiome field.

Notably, A. soehngenii is the first live, gut-native next-generation strain to receive a positive EFSA safety opinion under the European Novel Food Regulation. This highlights the strength of both the scientific evidence and the regulatory dossier supporting this innovation.

The positive opinion is a key step towards commercialisation in the EU, creating new opportunities for Winclove Probiotics and its business partners to develop and market products featuring this pioneering strain.

What makes A. soehngenii so special?

A. soehngenii is a next-generation probiotic targeting metabolic health through modulation of the gut microbiome.

A naturally occurring member of the human intestinal microbiota, the strain stands out for its distinctive metabolic pathway. What sets A. soehngenii apart is not simply that it produces butyrate, but how it does so. The bacterium uses lactate and acetate already present in the gut to produce butyrate, while also producing propionate, two key short-chain fatty acids involved in communication between the gut microbiota and the host.

Its ability to consume lactate while producing beneficial metabolites is particularly relevant in the context of impaired glucose metabolism, where disruptions in microbial and host lactate metabolism have been observed.

Supporting cardiometabolic health

Building on these unique metabolic properties, A. soehngenii has been broadly investigated for its role in cardiometabolic health.
By supporting insulin sensitivity, healthy glucose regulation and the reduction of low-grade inflammation, it may help reduce glycaemic variability and promote metabolic resilience.
These benefits may contribute to more stable energy levels and better long-term metabolic health across a broad spectrum of consumer needs, ranging from metabolic wellness and healthy ageing to support for individuals with impaired glucose metabolism.

Key differentiators

Unique lactate/acetate-to-butyrate conversion pathway
Consumes lactate and acetate while producing butyrate and propionate, supporting beneficial host-microbiome metabolic interactions.
Targets multiple drivers of metabolic dysfunction
Supports insulin sensitivity, healthy glucose regulation and reduction of low-grade inflammation.
Bridges wellness and metabolic health management
Relevant across the metabolic health continuum, from proactive healthy ageing and metabolic wellness to support for individuals with prediabetes or type 2 diabetes alongside lifestyle interventions and standard care.

From breakthrough science to product innovation

Turning scientific potential into practical probiotic applications lies at the heart of everything we do. As interest in solutions that support metabolic health continues to grow, we have spent the past year developing product concepts featuring A. soehngenii, both as a stand-alone strain and as part of innovative multi-strain formulations.
While the European approval process is not yet complete, today’s announcement represents a significant step towards market introduction and future availability.

Next step: European Commission authorisation

EFSA’s positive opinion concludes the scientific safety assessment stage. Market authorisation will follow after a final decision by the European Commission.

We look forward to exploring the opportunities this special strain offers and to working with our partners to advance the next generation of microbiome solutions.