| Background and Aims:Crohn's disease(CD)is a chronic,non-specific,inflammatory disease,which is one type of the inflammatory bowel disease.In recent years,intestinal micro-ecological changes have been a new target for treatment.Thus,fecal microbiota transplantation(FMT)have been used in the treatment of CD patients and it has been proved to be effective.Protein-energy malnutrition is susceptible for CD patients due to deficiency of intake and malabsorption.It has been reported that the conbination of FMT and enteral nutrition(EN)not only can induce and remain clinical remission effectively,but also can improve patients' nutritional status.The aims of this study are to explore the clinical remission rate,nutritional changes and the safety of this therapy strategy,and thus to explore whether the time of FMT can affect the efficacy of this integrative therapy strategy.Methods:This is a randomized,open-labeled and single-center research.Patients who are moderate to severe CD and aged from 18 to 70 are included.Patients' clinical history,demographic data,physical examination results,laboratory examination results and other relevant datas are collected after the patients signed the information consent form.All the patients were assigned to group FMT-Dayl and group FMT-Day7 randomly after the selection according to the inclusion and exclusion criteria.Then all included patients received FMT therapy through mid-gut at day 7 or 14 in group FMT-Dayl and group FMT-Day7 respectively,and all patients received exclusive EN(EEN)for the whole 2-week research period.Patients' information before the therapy,at day 7 and day 14 were collected.The clinical remission and improvement rate,nutritional status changes and the safety of this two groups were analysized before therapy,at day 7 and 14 respectively.Results:1.The clinical remssion rate in group FMT-Dayl and group FMT-Day7 is 71.4%and 57.1%(P>0.05)on day 7,and the clinical improvement rate is 85.7%and 85.7%(P>0.05)respectively.On day 14,the clinical remission rate in group FMT-Day1 and group FMT-Day7 is 83.8%and 80%(P>0.05),and the clinical improvement rate is 83.3%and 100%(P>0.05).2.On day 7,14 and before therapy,the changes in CRP,total protein,Alb,P-Alb,Plt,CDAI and HBI have significant differences in group FMT-Dayl(P=0.018,0.022,0.039,0.018,0.039,0.002 and 0.004 respectively).In detail,on day 7 and 14,CRP,CDA and HBI was significantly decreased while Alb and P-Alb was significantly increased.Total protein seemed to be increased but has no significance(P>0.05).Compared with the initial,the Plt was increased on day 7,and was decreased on day 14,but has no significance.3.On day 7,14 and before therapy,the changes in Alb,CDAI and HBI have significant differences in group FMT-Day7(P=0.05,0.015 and 0.008 respectively).Specifically,Alb was increased on day 7,which was not significantly important(P=0.553),however,it was significantly increased on day 14(P=0.043).CDAI and HBI were all significantly decreased on day 7 and 14 compared with initial(P<0.05).4.On day 7,the percentage of neutrophils in group FMT-Dayl was decreased significantly than group FMT-Day7(Z=-2.571,P=0.01),while the lymphocyte count in group FMT-Day7 was significantly increased than group FMT-Day1(Z=-2.146,P=0.032).On day 14,there was no difference between two groups.5.On day 7,HBI was all decreased in both groups compared with initial,but there was no significance between this two groups(Z=-1.415,P=0.157),so is CDAI(Z=-0.958,P=0.338).HBI was decreased in both groups compared with initial on day 14,but it had no significance(Z=-0.762,P=0.446).So is CDAI(Z=-0.913,P=0.461).Conclusion:This pragmatic study indicates that for CD patients accompanied with malnutrition,FMT combined with EN can induce clinical remission rapidly,and can improve patients' nutritional status at the same time.In addition,there were no severe adverse events during the research.In our research,when to receive FMT therapy seems to has no influence on the efficacy.However,early combination of FMT with EN showed more therapeutic benefits. |
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