The Safety of Fecal Microbiota Transplantation for Crohn’s Disease: Findings from A Long-Term Study

Abstract

IntroductionFecal microbiota transplantation (FMT) has been used as a potential treatment option for Crohn’s disease (CD). However, there is still lack of safety and efficacy evidence based on large samples of CD undergoing FMT. This study aimed to evaluate the risk factors of adverse event (AE) in the long term and the efficacy of FMT in the short term for patients with CD.MethodsFMT via mid-gut for mild to severe CD in a single center trial (NCT01793831) was performed from October 2012 to December 2016. The possible factors with AE and efficacy after FMT were prospectively recorded.ResultsA total of 184 frequencies of FMT were performed for 139 patients who received FMT. During 1 month after FMT, 13.6% of mild AEs occurred, including increased frequency of defecation, fever, abdominal pain, flatulence, hematochezia, vomiturition, bloating and herpes zoster. No AE beyond 1 month was observed. Therefore, a 1 month cut-off could be suggested to define short-term and long-term AEs of FMT. Among the possible risk factors, only fecal microbiota purification methods were closely associated with the occurrence of AEs. The rate of AEs in patients undergoing manual methods for the preparation of fecal microbiota was 21.7%, which was significantly higher than the 8.7% in those experiencing an automatic method. The manual or automatic purification of fecal microbiota had no correlation with the efficacy of FMT.ConclusionThis cohort study based on the largest size of cases demonstrated that improved fecal microbiota preparation reduced the rates of AEs, but did not affect the clinical efficacy in patients with CD.

Efficacy of faecal microbiota transplantation in Crohn’s disease: a new target treatment?

“…The safety of FMT in CD has been reported by our group recently (Wang et al, 2018). In this study, no long-term (> 1 m) FMT-related AEs were observed.…”

“…The clinical efficacy of FMT reported in the present study was consistent with those reported in our previous studies (Cui et al ., ; He et al , ; Wang et al , ). In the multivariate analysis, long disease duration (> 5 years) and moderate or severe disease (HBI ≥ 8) were associated with poor response to FMT.…”

Profound remission in Crohn’s disease requiring no further treatment for 3–23 years: a case series

“…We propose that the inability to clear MAP from the macrophage and the resulting dysbiosis from viable mycobacteria, leads to granulomas and the relapsing, remitting behaviour observed in CD. Targeting both steps is likely key to higher eradication and recovery rates and a reason as to why efficacy of FMT alone is currently sub-optimal in remission of CD [43]. However, there may be certain circumstances in a minority where recovery of the dysbiosis alone (by FMT only) may be sufficient in clearing/containing MAP, perhaps through restoration of the (innate) immune system functioning.…”

Washed microbiota transplantation vs. manual fecal microbiota transplantation: clinical findings, animal studies and in vitro screening

“…It has been recommended for the treatment of recurrent Clostridioides difficile infection (CDI) in the clinical guideline, consensus and joint-experts recommendation (McDonald et al, 2018;Ng et al, 2019). Increasing published randomized controlled trials (RCTs) and real-world studies demonstrated that FMT is of important therapeutic value in diseases beyond CDI, such as ulcerative colitis (UC) (Moayyedi et al, 2015;Paramsothy et al, 2017;Costello et al, 2019;Ding et al, 2019;Sood et al, 2019), Crohn's disease (CD) (Wang et al, 2018), hepatic encephalopathy (Bajaj et al, 2017), and autism (Kang et al, 2017). Tracing the origins of FMT in the world medical history, the earliest record of FMT for the treatment of human diseases began at least in the 4th century in China (Zhang et al, 2012).…”