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Oral faecal microbiota transplant therapy efficacious in UC

Presented by
Dr Craig Haifer, University of Sydney, Australia
ECCO 2021
Patients with ulcerative colitis (UC) who received oral administration of faecal microbiota transplant (FMT) therapy after antibiotic treatment had higher clinical remission rates and endoscopic remission/response rates, compared with patients who received antibiotic treatment alone. Clinical and endoscopic remission were preserved during FMT maintenance therapy.

FMT therapy has demonstrated patient benefits for inflammatory bowel disease (IBD) [1]. In the double-blind, randomised controlled LOTUS trial (ACTRN12619000611123), Dr Craig Haifer (University of Sydney, Australia) and colleagues investigated the effects of orally administered FMT therapy after a pre-treatment of antibiotics (n=15) versus treatment with antibiotics alone (n=20) in patients with mild-to-moderate UC [2]. Subsequently, FMT responder were re-randomised to FMT maintenance therapy (n=4) or FMT withdrawal (n=6). The primary endpoint was steroid-free clinical remission and endoscopic remission/response at week 8 and week 56 for induction therapy and maintenance therapy respectively.

The primary endpoint was met for 54% of the patients in the FMT arm versus 15% of the patients in the placebo arm. Clinical remission rates were 73% for patients receiving FMT therapy and 25% for patients receiving placebo. All patients enrolled in the maintenance FMT therapy showed clinical and endoscopic remission at week 56, whereas all patients randomised to FMT withdrawal experienced disease flare. In addition, IBD questionnaire scores demonstrated a reduced quality of life for patients in the withdrawal arm compared with patients in the maintenance arm.

Adverse events occurred in 47% of the patients in the FMT arm and in 90% of the patients in the placebo arm. There were 2 cases of severe adverse events in both arms of the trial. Dr Haifer concluded that FMT therapy was well tolerated and feasible in this population. Furthermore, he argued that the potential enhanced efficacy of FMT therapy due to pre-treatment with antibiotics should be investigated in-depth.

  1. Paramsothy S, et al. J Crohns Colitis 2017;11(10):1180-1199.
  2. Haifer C, et al. Lyophilised Orally administered FMT therapy in Ulcerative colitis (LOTUS) study. OP30, ECCO 2021 Virtual Congress, 2-3 & 8-10 July.


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