Oral fecal microbiota transplantation induces, maintains remission in ulcerative colitis
Oral lyophilized fecal microbiota transplantation following antibiotic use induced and maintained remission in patients with active ulcerative colitis, according to research published in Lancet Gastroenterology and Hepatology.
“FMT delivered via colonoscopic infusion and enemas induces clinical remission in 24% to 47% of patients with active ulcerative colitis. However, this route of administration is invasive, poorly tolerated and logistically difficult due to storage and transport requirements,” Craig Haifer, MBBS, FRACP, of the University of Sydney’s Concord Clinical School and the departments of gastroenterology at Concord Repatriation General Hospital and St. Vincent’s Hospital, and colleagues wrote. “Orally administered FMT has similar efficacy to FMT delivered via colonoscopy in the treatment of recurrent or refractory Clostridioides difficile colitis although it remains unclear whether it has clinical efficacy in ulcerative colitis.”
In a randomized, double-blind, placebo-controlled trial, researchers assessed the safety and efficacy of oral lyophilized FMT compared with placebo among 35 patients aged 18 years to 75 years with active UC. Following a 2-week course of pretreatment antibiotics comprised of amoxicillin 500 mg three times daily, doxycycline 100 mg twice daily and metronidazole 400 mg twice daily, patients were randomly assigned to receive either oral FMT (n = 15) or placebo (n = 20) for 8 weeks; FMT responders either continued FMT treatment or withdrew for another 48 weeks. The primary endpoint was corticosteroid-free clinical remission with endoscopic remission or response.
According to study results, 53% of patients in the FMT group and 15% of patients in the placebo group achieved the primary endpoint (OR = 5; 95% CI, 1.8-14.1). Further, 73% and 25% of patients achieved corticosteroid-free clinical remission (OR = 5.8; 95% CI, 2.2-15.4) and 47% and 15% of patients achieved corticosteroid-free endoscopic remission (OR = 4.4; 95% CI, 1.1-17.7). Haifer and colleagues noted no significant difference in endoscopic response (53% vs. 40%) or clinical response (73% vs. 45%).
Of the patients who achieved clinical or endoscopic response within the FMT group, 10 patients entered the maintenance period to either continue open-label FMT (n = 4) or withdraw (n = 6). Compared with the patients who underwent FMT withdrawal, 100% of patients who continued FMT therapy achieved clinical, endoscopic and histologic remission at week 56.
“An all-oral regimen of FMT is a promising therapy for the induction and subsequent maintenance of remission in patients with ulcerative colitis and builds upon the existing literature surrounding microbial manipulation therapy,” Haifer and colleagues concluded. “A differential therapeutic efficacy of FMT sourced from distinct donors was identified; further studies assessing donor differences and their effect on therapeutic outcomes is essential and has the potential to further optimize FMT donor selection and guide the development of next generation microbial manipulation therapies.”