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P387 Efficacy of combination therapy of fresh faecal microbiota transplantation and triple-antibiotic therapy for ulcerative colitis

D. Ishikawa*1, M. Takahashi1, K. Okahara1, S. Ito1, K. Haga1, T. Shibuya1, T. Osada2, A. Nagahara1

1Juntendo University, Gastroenterology, Tokyo, Japan, 2Juntendo Urayasu Hospital, Gastroenterology, Urayasu, Japan

Background

We previously demonstrated that fresh faecal-microbiota transplantation (FMT) following triple-antibiotic therapy [amoxicillin, fosfomycin, and metronidazole (AFM); A-FMT] induced dramatic changes in the phylum Bacteroidetes, which constitutes a critical factor correlated with clinical responses.1 Furthermore, we also reported that A-FMT combination therapy contributed to the microbiological improvement of intestinal dysbiosis in UC patients via successful transplantation of live Bacteroidetes cells from donors.2 Eradication of dysbiotic indigenous Bacteroidetes species by AFM pre-treatment may promote the entry of living Bacteroidetes cells, thereby improving the dysbiosis of intestinal microbiota induced by UC. Here, we evaluated the efficacy of A-FMT compared with AFM monotherapy and examined factors correlated with clinical response.

Methods

This was an open-label, non-randomised, prospective control study. These patients were diagnosed with active UC, with a Lichtiger’s Clinical Activity Index (CAI) of 5 or more, or with an endoscopic Mayo clinic score of 1 or more, between July 2014 and March 2017. Patients’ spouses or relatives were selected as donor candidates. AFM was administered to patients with UC for 2 weeks, and up to 2 days before fresh FMT. Donor faecal samples were collected on the day of administration and transferred into the patient’s colon via colonoscopy within 6 h. The clinical features of UC were judged using CAI before treatment and 4 weeks after treatment. Clinical responses were defined as a CAI of less than 10 points and a decrease of 3 or more points, and clinical remission was defined as a CAI of 3 points or less.

Results

Patients with mild-to-severe active UC (n = 55 A-FMT; n = 37 AFM) were included in this assessment. Seventy-nine patients completed this assessment (n = 46 A-FMT; n = 32 AFM). At 4 weeks after treatment, clinical responses and were observed in 31 patients {Per Protocol Set (PPS): 67.3%) in A-FMT, which higher than in AFM (PPS:56.2%)}. In A-FMT, the clinical remission was observed to be higher than AFM (A-FMT41.3%, AFM18.7%; p = 0.06). In A-FMT, endoscopic sum score was associated with clinical responses (responders 7.5 ± 3.2, non-responders 5.1 ± 3.6; p = 0.03), and clinical responses and remission were significantly higher in proctitis than other type of colitis (n = 38, 8; p = 0.03, p = 0.005). In addition, decrease of CAI was significantly higher in users of anti-TNFα and PSL than in non-users (p = 0.01, p = 0.01). These factors correlated with clinical responses were not observed in AFM monotherapy.

Conclusion

Further follow-up studies are required to evaluate the long-term efficacy of this FMT protocol, and it is possible that this protocol may become a useful strategy for the management of patients with UC.

References

1. Ishikawa D, Sasaki T, Osada T, et al. Changes in intestinal microbiota following combination therapy with fecal microbial transplantation and antibiotics for ulcerative colitis. Inflamm Bowel Dis 2017;23:116–125.

2. Ishikawa D, Sasaki T, Takahashi M, et al. The microbial composition of bacteroidetes species in ulcerative colitis is effectively improved by combination therapy with fecal microbiota transplantation and antibiotics. Inflamm Bowel Dis 2018;24:2590–2598.