ACTRN12613000236796 - Fecal Microbiota Transplantation (FMT) & Ulcerative Colitis (UC)

Background:

In recent studies, high-intensity fecal microbiota transplantation (FMT) that is aerobically prepared has shown effectiveness in treating active ulcerative colitis (UC). By utilizing anaerobic stool processing methods, FMT protocols may improve the viability of microbes, potentially achieving effective results with a reduced intensity of treatment (1).

Study overview:

It is a multicenter, randomized, double-blind clinical treatment trial evaluating Fecal Microbiota Transplantation (FMT) (anaerobically prepared pooled donor FMT vs. autologous FMT) in 73 randomized adults with mild to moderately active Ulcerative Colitis (UC) (1).

Primary outcome measures:

In the context of ulcerative colitis (UC), achieving steroid-free remission is characterized by a total Mayo score of 2 or less, with an endoscopic Mayo score of 1 or lower, by the eighth week. The total Mayo score, which is used to assess the severity of UC, ranges from 0, indicating no disease, to 12, representing the most severe form of the disease. The status of steroid-free remission in UC patients was evaluated again at the 12-month mark (1).

Results:

In the study involving 73 patients with an average age of 39 years, of whom 33 were women (45%), 69 participants (95%) completed the trial. The primary outcome was observed in 12 out of 38 participants (32%) who received pooled donor FMT, compared to 3 out of 35 participants (9%) who received autologous FMT. This resulted in a difference of 23% with a 95% confidence interval ranging from 4% to 42%, and an odds ratio of 5.0 with a 95% confidence interval from 1.2 to 20.1, with a P-value of .03. Additionally, five out of the 12 participants (42%) who achieved the primary endpoint at week 8 after receiving donor FMT remained in remission at 12 months (1).

Conclusion:

In this initial investigation involving adults with mild to moderate ulcerative colitis (UC), a one-week treatment using anaerobically prepared donor fecal microbiota transplantation (FMT) was compared to autologous FMT. The results indicated a greater probability of achieving remission at the eight-week mark with the donor FMT. However, additional research is necessary to evaluate the long-term maintenance of remission and the safety of this treatment approach (1).

References:

(1) Costello et al. 2019a JAMA 321: 156–164