Clinical Efficacy And Safety Of Fecal Bacteria Transplantation In The Treatment Of Inflammatory Bowel Disease

Background and Aim:The gut microbiota plays a pivotal role in the intestinal diseases.Fecal microbiota transplantation(FMT)might be a rescue therapy for refractory inflammatory bowel disease.This study aimed to evaluate the safety,feasibility and efficacy of FMT through mid-gut for refractory Crohn’ s disease(CD).Methods:We established standardized laboratory protocol and clinical work flow for FMT.Only refractory CD patients with Harvey-Bradshaw Index(HBI)score>7 were enrolled for this study.All included patients were treated with single FMT through mid-gut and assessed during follow-up.Results:Metagenomics analysis showed a high concordance between feces sample and purified fecal microbiota from same donors.Standardized fecal microbiota preparation and clinical flow significantly simplified the practical aspects of FMT.In total,30 patients were qualified for the present analysis.The rate of clinical improvement and remission based on clinical activity at the first month was 86.7%(26/30)and 76.7%(23/30)respectively,which was higher than other assessment points within 15-month follow-up.Patients’ body weight increased after FMT,and the lipid profile improved as well.FMT also showed a fast and continuous significant effect in relieving the sustaining abdominal pain associated with sustaining CD.Conclusions:This is a pilot study with the largest sample of patients with refractory CD underwent single FMT.The results demonstrated that FMT through mid-gut might be a safe,feasible,and efficient rescue therapy for refractory CD.Background:The strategy of using fecal microbiota transplantation(FMT)for refractory ulcerative colitis(UC)remains unclear if single FMT failed to induce remission.This study aimed to evaluate the efficacy and safety of a designed step-up FMT strategy for the steroid-dependent UC.Methods:Fifteen patients with steroid-dependent UC were enrolled,and treated with step-up FMT strategy.Follow-up clinical data was collected for a minimum of 3 months.Fecal microbiota composition before and post FMT of patients and related donors were analyzed by 16S rRNA sequencing.Results:Eight of fourteen(57.1%)patients achieved clinical improvement and were able to discontinue steroids following step-up FMT.One patient was lost to follow-up.Among the 8 patients who responded,five(35.7%)received one FMT therapy,one(7.1%)received two FMTs,and two(14.2%)received two FMTs plus a scheduled course of steroids.Four(28.6%)of the 8 patients who responded maintained long-term remission during follow-up(3-18 months).Six patients(42.9%)failed to meet the criteria of clinical improvement and maintained steroid dependence,though 3 experienced transient or partial improvement.Microbiota analysis showed that FMT altered the composition greatly,and a microbiota composition highly similar to that of the donor emerged in the patients with successful treatment.No severe adverse events occurred during treatment and follow-up.Conclusions:step-up FMT strategy shows promise as a therapeutic strategy for patients with steroid-dependent UC,likely due to the successful restructuring of gut microbial composition.Trial registration:ClinicalTrials.gov,Number NCT01790061.