FMT superior to placebo for remission induction in ulcerative colitis patients
Faecal microbiota transplant (FMT) is more effective than placebo for induction of remission in patients with ulcerative colitis (UC), while having no major short-term safety signals, according to a meta-analysis.
Researchers searched multiple electronic databases for cohort studies and randomized controlled trials (RCTs) reporting remission rates following FMT for active UC. The Cochrane risk of bias tool was used in the assessment of bias in the studies.
A total of 14 cohort studies and four RCTs using markedly different protocols were included. Pooled data from the RCTs revealed that clinical remission was achieved with greater frequency in the donor FMT groups (39 of 140 patients) than in the placebo groups (13 of 137 patients; 28 vs 9 percent). UC patients who received FMT were 3.67 (95 percent CI, 1.82 to 7.39) times as likely as those who received placebo to achieve clinical remission (p<0.01).
The proportion of patients with clinical response was similarly higher in the FMT group (69 of 140 patients) than in the placebo group (38 of 137; 49 vs 28 percent), yielding an odds ratio of 2.48 (1.18 to 5.21; p=0.02).
Pooled data from cohort studies showed that 93 of 168 patients (55 percent; 36.7 to 71.7) who received FMT had clinical response. Among responders, 39 achieved clinical remission (24 percent; 11 to 40).
Occurring at the interface between the luminal contents and the mucosal immune system, UC is a chronic, elapsing and remitting inflammatory disease of the colon. The colonic microbiome has been implicated in the pathogenesis of the disease, with luminal bacterial antigens contributing to immune cell activation. [Gastroenterol Clin North Am 2017;46:143-154; Lancet 2016;387:156-167; Inflamm Bowel Dis 2012;18:372-390]
Most medical therapies available to date target the immune response without modifying the luminal microbial environment. However, such ‘immunocentric’ therapies have incomplete efficacy and are sometimes limited by side effects including allergy, intolerance, serious infection, increased risk of malignancy, drug antibody formation and cost. [Pharmacogenetics 2002;12:429-436]
Despite variation in processes, FMT appears to be effective for induction of remission in UC, with no major short-term safety signals. Further studies are needed to better define dose frequency and preparation methods, and to explore its feasibility, efficacy and safety as a maintenance agent.
Findings of the present study highlight the efficacy and safety of FMT for the induction of remission in patients with UC. Further research is needed to identify optimal dose frequency and preparation methods, as well as to further explore FMT’s feasibility, efficacy and safety as a maintenance agent, researchers said.