Multiple Fresh Fecal Microbiota Transplants Induces And Maintains Clinical Remission In Crohn’s Disease Complicated With Inflammatory Mass

Background and Aims:The ancient Chinese medical literature,as well as our prior clinical experience,suggests that fecal microbiota transplantation(FMT)could treat the inflammatory mass.We aimed to evaluate the efficacy and safety of multiple FMTs for Crohn’s disease(CD)complicated with intraabdominal inflammatory mass.Methods:We conducted a prospective open-label trial.Patients with moderate to severe CD and diagnosed with CD-associated inflammatory mass by CT or MRI were recruited.The steroid,antibiotics and other CD medications were required to be stopped after inclusion.Mesalazine by oral daily was given as a supplemental treatment.All patients received initial FMT followed by repeated FMTs every 3 months.The FMT was administrated through the middle-gut using gastroscope.Base on Harvey-Bradshaw index(HBI),Clinical remission was defined as HBI score≤4.Sustained clinical remission was defined as remission induced by the initial FMT within one month and then maintained remission(without any relapse)under FMTs during the follow-up.Clinical improvement was defined as a decrease of HBI>3,and HBI>4.The primary endpoint was clinical response(improvement and remission)and sustained clinical remission at 12 months.Secondary endpoints were improvement in size of phegmon/abscess based upon cross-sectional imaging and safety of FMT.Results:25 CD patients complicated with intraabdominal inflammatory mass were analyzed in this study.Disease duration was 6.2±3.91 years,HBI was 11.0±2.68,the percentage of patients with steroid dependent was 40%.22 patients complicated with abdominal phegmon and 3 complicated with abdominal abscess.68.0%(17/25)and 52.0%(13/25)of patients achieved clinical response and clinical remission at 3 months post the initial FMT,respectively.The proportion of patients at 6 months,12 months and 18 months achieving sustained clinical remission with sequential FMTs was 48.0%(12/25),32.0%(8/25)and 22.7%(5/22),respectively.HBI score significantly decreased(P<0.05)at each assessment point compared with the baseline.CRP significantly decreased at the third day after FMT(media 18.50 IQR 11.25-55.25 vs.media 11.0 IQR 9.0-20.0,P=0.012).Both hemoglobin at three months assessment point(99.18 ± 18.87 vs.110.27 ± 23.28,p=0.045)and albumin(33.27 ± 7.77 vs.38.26± 8.55,p=0.036)significantly increased respectively.9.5%(2/21)of patients achieved radiological healing and 71.4%(15/21)achieved radiological improvement.3(12%)patients underwent surgery during the follow-up.No severe adverse events related to FMT were observed.The main adverse events were fever,abdominal pain and anal pain.Conclusion:The sequential fresh FMTs might be a promising,safe and efficacious therapy to induce and maintain clinical remission in CD with intraabdominal inflammatory mass.This pragmatic study opens a new window to the future treatment of CD-related chronic penetrating complication.