Orally-administered FMT maintenance therapy for over a year has been shown effective in patients with ulcerative colitis.
The final results from the Australian LOTUS Study showed daily FMT capsules maintained the clinical remission seen after an induction phase – as previously reported in the limbic – and extended the response to include endoscopic and histological healing.
The study comprised 35 patients who received two weeks of ‘priming’ antibiotics, targeting Fusobacterium which are associated with a poorer response to FMT, then eight weeks of oral FMT versus placebo.
After the induction phase, 10 patients who achieved corticosteroid-free clinical or endoscopic response were randomised into 48 weeks of either maintenance FMT therapy or FMT withdrawal.
The study, published in The Lancet Gastroenterology & Hepatology, found all (100%) patients who continued FMT were in clinical, endoscopic and histologic remission at week 56 compared to none (0%) in the FMT withdrawal group.
The median time to UC relapse was 24 weeks and all patients in the FMT withdrawal group required rescue therapy
Meanwhile, patients on the FMT maintenance therapy experienced ongoing improvements in faecal calprotectin and quality of life.
The study found no patient factors were able to predict who would respond to therapy but there was a strong donor effect on treatment outcomes.
Senior investigator Professor Rupert Leong told the limbic that one of the two donors was clearly a “super donor”.
“There were two donors and each provided the full donation during the patient’s journey. One of them had 100% efficacy rates which means that their stool is more effective in inducing the response in UC than the second donor.”
“We tried to optimise the donors by selecting who we thought would generate the best response but there is something that we can’t account for that favours Donor 1 over Donor 2.”
Professor Leong, from the Concord Repatriation General Hospital and University of Sydney, said the FMT effect appears to be completely independent of the patients’ medical therapy.
“So it does look like there is an activity for inducing remission but more importantly, continued treatment can also lead to sustained remission.”
“I think the paradigm at the moment is that if patient has undergone mucosal healing – so they have deep remission with clinical remission plus endoscopic healing plus histological healing – it does give us more leeway to withdraw their therapy.”
“That is something that we will have to get more data on with experience over time.”
The study said the response to oral FMT therapy appeared to be higher than in the FOCUS study in which FMT was delivered by colonoscopy infusion and enemas.
Larger studies, not interrupted by COVID-19, and a better understanding of factors determining donor efficacy were warranted.