An increasing number of patients with inflammatory bowel disease (IBD) are asking about faecal transplants and whether they work in treating colitis. Several studies have reported about the important role of the gut microbiota in IBD. Faecal microbiota transplant (FMT) is the process of transferring stool into a patient’s GI tract to repopulate the gut with healthy intestinal bacteria. In FMT, faecal matter is collected from healthy individuals who are screened to determine that the stool is safe for transplantation. The stool is processed and prepared for use, then placed in patients via methods such as colonoscopy, endoscopy or enema.
This treatment is currently very effective in recurring Clostridium difficile infections (gut infection causing diarrhoea). FMT has gained more interest as an alternative treatment option for IBD. There have been many studies describing FMT as therapy for IBD. However, most of these studies have been limited to small case studies and have reported varying efficacy. To date, good clinical trials investigating the efficacy of FMT in the treatment of ulcerative colitis (UC) have been limited.
This year at the European Crohn’s and Colitis Organization 2016 Congress (a gathering of world experts in IBD), a very exciting new study was presented by researchers in Australia. Dr. Paramsothy and his team recruited 81 patients across three Australian study sites: 41 patients received FMT treatment and 40 patients received a placebo (non-active treatment). All patients presented with active UC and were refractory to standard non-biologic treatment. Steroids were permitted, but were tapered to zero during the study period. The primary combined endpoint was endoscopic response on flexible sigmoidoscopy and clinical remission and response at eight weeks and 16 weeks. Patients received the first FMT and placebo treatment through a colonoscope. Subsequently, participants were given enemas that were self-administered five days per week for eight weeks.
After eight weeks, more than three times as many FMT patients responded to treatment than those in the control group. Specifically, 11 of the 41 FMT patients (27%) achieved the study’s primary goal and reported no UC symptoms and doctors determined the lining of the digestive tract had healed or substantially improved. Only three of the 40 patients (8%) in the control group reached this goal. When researchers looked at the number of patients reporting being symptom-free (and discounted clinician observation of the colon), they found that 44% of FMT patients reported improvement versus 20% in the control group. There was no difference in adverse events between the two groups.
The researchers conclude that the study is the first multi-centred trial that uses an intense therapy of FMT infusions, 40 over eight weeks, and has been able to show definitively that faecal microbiota transplantation is an effective treatment for ulcerative colitis.
This study is important for many reasons. This is the largest, randomised controlled trial examining the efficacy of FMT in UC. In this study, each FMT enema consisted of stool from at least three donors to ensure that study results were not influenced by a “donor effect”, in which individual patient outcomes may be unduly influenced by the microbial characteristics of a single donor. In addition, patients with UC are accustomed to using enemas as part of previous treatment. As such, the approach used in this study would not be unusual and patients are likely to accept the therapy more readily.
A limitation of this study is that specific microbial analysis, which may identify the most effective strains of bacteria, was missing. It would be more useful to identify the exact groups of bacteria that are beneficial in this population and to administer only these to patients.
Nonetheless, the results are very encouraging and, in my opinion, will influence our practice in the very near future.
Dr Protima Amon
European Crohn’s and Colitis Organisation (ECCO) 2016 Congress: Abstract OP017. Presented March 18, 2016.