NCT02865616 - Microbial Ecosystem Therapeutics 2 (MET-2) & Clostridioides difficile infection (CDI) (recurrent)

Background

Faecal microbiota transplantation (FMT) is effective for treating recurrent Clostridioides difficile infection (1)

Study overview

It is phase I, open-label, single-group feasibility trial studying Microbial Ecosystem Therapeutics 2 (MET-2) (10 oral capsules daily for 2 days, 3 capsules daily for 8 days) in 19 adult patients (analyzed) with mild to moderate C difficile infection (at least one recurrence of C difficile infection within 12 months) (1)

Primary outcome measures

No recurrence of C difficile infection by day 40 (defined as fewer than three unformed bowel movements in 24 hours persisting for at least 2 days) (1)

Results

Recurrent C difficile infection absent in 15 (79%) of 19 patients at day 40 post-initial treatment, increased to 18 (95%) at day 40 post-retreatment
No mortality linked to C difficile infection or MET-2 treatment
Symptoms

• Diarrhoea in 12 (63%) of 19 patients


• Abdominal cramps in 12 (63%)
  Long-term Outcome:


• 16 (84%) of 19 patients did not experience recurrence by day 130

Conclusion

MET-2 seems to be a safe, effective, and well-tolerated option for patients experiencing recurrent C difficile infections. However, it is important that these results are confirmed through controlled studies (1)

References

(1) Kao et al. 2021 Lancet Gastroenterol Hepatol 6(4): 282-291