HCP – IBS Study

IBS Study

Study to determine whether pasteurised Akkermansia muciniphila improves bowel and psychological symptoms in subjects with Irritable Bowel Syndrome

Overview

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

Main objectives

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

Methods

Design exploratory, randomised, 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).
IBS-Clinical-Study-Results

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.
1

Key Takeaway

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

REFERENCES 

1 (REF 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).