IDDF2018-ABS-0220 Faecal microbiota transplantation for maintenance of clinical remission in patients with active ulcerative colitis: a randomised control trial

Abstract

Background Though faecal microbiota transplantation (FMT) has been shown to be efficacious for induction of remission in patients with active UC, the long-term clinical outcomes after initial response have not been assessed. Methods This single-blind, randomised, placebo-controlled trial was conducted at Dayanand Medical College and Hospital, India. Patients with active UC (Mayo score 4–10) who achieved clinical remission with multi-session FMT (0, 2, 6, 10, 14, 18 and 22 weeks) were randomly allocated in a 1:1 ratio to either maintenance FMT or placebo colonoscopic infusion every 8 weeks till 48 weeks. The primary endpoint was the maintenance of steroid-free clinical remission (Mayo score ≤2), and secondary endpoints were the achievement of deep remission (clinical and endoscopic remission, i.e. endoscopic Mayo score 0) and histological remission (Nancy grade 0, 1) at the end of 48 weeks. Clinical disease activity and adverse events were assessed at each visit or earlier in case of worsening of symptoms. The analysis was done by intention-to-treat and included all patients who underwent one session of FMT after initial clinical remission at week 22. Results Forty-three of 78 patients treated with multi-session FMT achieved clinical remission, 22 of these were randomly assigned to receive FMT and 21 received placebo, colonoscopically every 8 weeks. The primary outcome was achieved in 19/22 (86.4%) patients allocated FMT versus 14/21 (66.7%) patients assigned placebo (p=0.126). Secondary endpoints of deep remission [18/22 (81.8%) with FMT versus 8/21 (38.1%) with placebo p=0.003] and histological remission [12/22 (54.5%) with FMT versus 3/21 (14.3%) with placebo p=0.006] were achieved in a significantly higher number of patients with FMT. Two patients receiving FMT and 5 patients on placebo relapsed. All relapses were treated with steroids. There were no serious adverse events necessitating discontinuation in patients on FMT, 1 patient who relapsed on placebo required colectomy. Conclusions Maintenance therapy with FMT is required in patients who had earlier been treated with FMT for induction of remission. Moreover, FMT also enhances achievement of deep and histological remission.