IBS Study

Study to determine whether pasteurized Akkermansia muciniphila MucT™ improves bowel and psychological symptoms in subjects with Irritable Bowel Syndrome.

Overview

Irritable bowel syndrome (IBS) is a disorder of gut-brain interaction (DGBI) characterized by recurrent abdominal pain5 and abnormal bowel habits. Akkermansia muciniphila is a next-generation beneficial microbe. In both live and pasteurized form (pAKK) it is shown to improve gut barrier function.1

 

Main objectives

Explore the impact of pasteurized Akkermansia muciniphila (pAKK) on IBS symptoms and psychological distress symptoms in subjects with IBS-SSS ≥175.

 

Methods

Design exploratory, randomized, double-blind, placebo-controlled, hybrid (F2F & online) pilot clinical trial testing oral intake of pAKK during 12 weeks in improving symptoms of IBS in 90 participants with IBS (not statistically powered).

 

To learn more about the Rome IV Criteria, click here.

 

What were the results?

  • Excellent tolerance and safety profile.
  • Clinically meaningful improvements in IBS-SSS in both arms in this mostly moderate IBS population, with slightly deeper response in absolute values by pAKK, and also reflecting an important placebo effect.
  • The placebo effect was dominant in the subjects with a lower IBS-SSS score at baseline. The higher the initial IBS-SSS value, the bigger the clinical effect by pAKK, with statistical tendency to be different from placebo.
  • Psychological parameters slightly improve in the pAKK arm while worsening in the placebo arm (statistically non-significant).

In the below abstract we describe the results in the IBS population with IBS-SSS of 175 or more at baseline.

 

 

Key Takeaway

These results further support the potential of pAKK to modulate the gut-brain interaction in IBS subjects.

 

References

  1. Plovier et al Nat Med 2017; Depommier et al Nat Med 2019) – pAKK also modulates the gut-brain axis (Abot et al Heliyon 2023).