Orally administered faecal microbiota transplantation (FMT) has shown promise in the early management of ulcerative colitis, the GESA AGW 2020 was told.
The findings support the results from previous RCTs of FMT delivered by colonoscopy and a meta-analysis which found FMT can induce clinical remission in about one-third of patients.
Recipient of the GESA Young Investigator Award (Clinical) Dr Craig Haifer told the virtual meeting that oral FMT offered a less invasive and more feasible approach than colonoscopic infusions especially for regular maintenance therapy.
The Lyophilised Oral Faecal Microbiota Transplantation in the Management of Ulcerative Colitis (LOTUS) study also incorporated pre-treatment with antibiotics and rationally selected donors in a bid to improve clinical efficacy.
Dr Haifer said the two-week pre-treatment with antibiotics (amoxicillin, metronidazole and doxycycline) targeted Fusobacterium species which have previously been shown to be detrimental to FMT efficacy.
And for the same reason, bacterial 16S RNA sequencing was used to identify donors with high levels of organisms including Bacteroides, Ruminococcaceae and Roseburia but not Fusobacterium.
The study had intended to enrol 64 patients but recruitment had to pause in March 2020 due to the COVID-19 pandemic.
Instead, 37 adults with mild-moderate disease for longer than three months were randomised to either daily FMT or placebo capsules for eight weeks.
Dr Craig Haifer, a gastroenterologist at Concord Hospital and a PhD candidate at the University of Sydney, said 50% of FMT-treated patients and 16% of placebo-treated patients achieved the primary endpoint of clinical remission and endoscopic remission or response (OR 4.63).
In secondary outcomes, steroid-free clinical remission at week 8 was significantly greater in the FMT than placebo-treated patients (49% v 26%; OR 5.33).
Steroid-free endoscopic remission was higher in the FMT group (44% v 16%; p=0.07) but like endoscopic response (50% v 42%; p=0.44) was not statistically significant.
Similarly, faecal calprotectin reduced in both groups but with a larger fall in the FMT group. Quality of life scores increased in both groups.
Dr Haifer said adverse events were typically self-limiting GI complaints. Severe adverse events, such as worsening colitis were occasionally seen in both groups (13% v 11%).
“The main limitation of our study was we did not meet our predetermined sample size calculation due to COVID pandemic,” he said.
“Recognising this, our results show significant promise and suggest that oral FMT is associated with increased rates of clinical remission and endoscopic remission or response versus antibiotic treatment alone.”
“There was no new safety signal identified and we found that incorporating rationally selected donors and the use of pre-treatment antibiotics may improve the efficacy of FMT compared to previously published RCT data.”
Dr Haifer said 10 patients have since entered the maintenance phase of the study.