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Comparisons of efficacy and safety of 400 or 800 ml bacterial count fecal microbiota transplantation in the treatment of recurrent hepatic encephalopathy: a multicenter prospective randomized controlled trial in China

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收录情况： ◇ SCIE

作者：
Zou Pengfei[1,2] * ; Bi Yunjiao[3] * ; Tong Zhaowei[4] * ; Wu Tao[5] ; Li Qiang[6] ; Wang Kai[7] ; Fan Yuchen[7] ; Zhao Dan[8] ; Wang Xin[9] ; Shao Hui[10] ; Huang Haijun[11] ; Ma Suping[12] ; Qian Yunsong[13] ; Zhang Guoqiang[14] ; Liu Xiao[15] ; Jin Qiaofei[16] ; Ru Qingjing[17] ; Qian Zhiping[18] ; Sun Wei[19] ; Chen Qiang[20] ; You Liying[21] ; Wang Fang[22] ; Zhang Xiaoting[23] ; Qiu ZhenXiong[24] ; Lin Qing[25] ; Lv Jiaojian[26] ; Zhang Yongping[27] ; Geng Jiawei[28] ; Mao Richeng[29] ; Liu Jinfeng[30] ; Zheng Yubao[31] ; Ding Feng[32] ; Wang Hui[33] ; Gao Hainv[34,35] ;
机构： [1]Shulan (Hangzhou) Hospital Affiliated to Zhejiang, Shuren University Shulan International Medical College, Hangzhou, China. [2]Jinan Microecological Biomedicine Shandong Laboratory, Jinan, China. [3]Zhejiang Chinese Medical University, Hangzhou, China. [4]Huzhou Central Hospital, Huzhou, China. [5]Hainan General Hospital Branch - Ding'an Hospital, Ding'an, China. [6]Shandong Public Health Clinical Center, Jinan, China. [7]Department of Hepatology, Qilu Hospital of Shandong University, Jinan, China. [8]Zhengzhou Third People's Hospital, Zhengzhou, China. [9]Shulan (Quzhou) Hospital, Quzhou, China. [10]Taizhou Hospital of Zhejiang, Taizhou, China. [11]Zhejiang Provincial People's Hospital, Hangzhou, China. [12]The First Affiliated Hospital of Henan University of CM, Zhengzhou, China. [13]Ningbo No.2 Hospital, Ningbo, China. [14]Luoyang Central Hospital, Luoyang, China. [15]Ningbo Zhenhai District People's Hospital, Ningbo, China. [16]Hangzhou Xixi HospitalAffiliated to, Zhejiang University School of Medicine , Hangzhou, China. [17]The Second Affiliated Hospital of Zhejiang, Chinese Medical University, Hangzhou, China. [18]Shanghai Public Health Clinical Center, Shanghai, China. [19]The First Affiliated Hospital of Soochow University, Suzhou, China. [20]Zouping People's Hospital, Binzhou, China. [21]ALMETTE Hospital &amp [22], The First Hospital of Kunming, Kunming, China. [22]Zoucheng People's Hospital, Jining, China. [23]Shenzhen Bao'an District Songgang People's Hospital, Shenzhen, China. [24]Baoan Central Hospital of Shenzhen, Shenzhen, China. [25]The People's Hospital of Jiulongpo District, Chongqing, China. [26]Lishui People's Hospital, Lishui, China. [27]People's Hospital of Xinjiang Uygur Autonomous Region, &#xdc [29]r&#xfc [30]mqi, China. [28]Department of Infectious Disease and Hepatic Disease, First People's Hospital of Yunnan Province, Affiliated Hospital of Kunming University of Science and Technology, Kunming, Yunnan, China. [29]Department Of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai, China. [30]The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. [31]Department of Infectious Diseases, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China. [32]Affiliated Hospital of Shaoxing University, Shaoxing, China. [33]Department of Infectious Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. [34]Shulan (Hangzhou) Hospital Affiliated to Zhejiang, Shuren University Shulan International Medical College, Hangzhou, China. hainv.gao@shulan.com. [35]Jinan Microecological Biomedicine Shandong Laboratory, Jinan, China. hainv.gao@shulan.com.
出处：
DOI： 10.1186/s13063-024-08578-9
ISSN：

关键词： Fecal microbiota Transplantation Recurrent hepatic encephalopathy

摘要：
Hepatic encephalopathy (HE) represents a critical complications of end-stage liver disease, serving as an independent predictor of mortality among patients with cirrhosis. Despite effective treatment with rifaximin, some patients with HE still progress to recurrent episodes, posing a significant therapeutic challenge. Recurrent HE is defined as experiencing two or more episodes within a 6-month period. Previous research has suggested that FMT may emerge as a promising treatment for recurrent HE. However, there remains a critical need to explore the optimal dosage. This trial aims to abscess the efficacy and safety of two FMT dosages: 800 ml or 400 ml total bacterial count, including mortality and quality of life.This multicenter, prospective, randomized controlled trial will enroll 100 eligible patients from 31 hospitals in China. Participants will be randomly assigned in a 1:1 ratio to either the high-dose group (800 ml total bacterial count) or the low-dose group (400 ml total bacterial count). The primary objective is to assess the efficacy and safety of both dosages on outcomes at 24 and 48 weeks, including mortality and quality of life.If either or both dosages of FMT demonstrate safe and effective treatment of recurrent HE, leading to improve quality of life and survival at 24 and 48 weeks, this trial would address a significant gap in the management of recurrent HE, carrying innovative and clinically significant implications.NCT05669651 on ClinicalTrials.gov. Registered on 29 December 2022. CHiCTR2200067135 on China Registered Clinical Trial Registration Center. Registered on 27 December 2022.© 2024. The Author(s).

基金：
National Key Research and Development Program of China (2021YFA1301104) and the Research Project of Jinan Microecological Biomedicine Shandong Laboratory.
语种：
外文
WOS：
PubmedID：
中科院(CAS)分区：
出版当年[2024]版：
无
最新[2023]版：
大类 | 4 区 医学
小类 | 4 区 医学：研究与实验
JCR分区：
出版当年[2023]版：
Q3 MEDICINE, RESEARCH & EXPERIMENTAL
最新[2023]版：
Q3 MEDICINE, RESEARCH & EXPERIMENTAL

影响因子： 最新[2023版] 最新五年平均 出版当年[2023版] 出版当年五年平均 出版前一年[2022版]

第一作者：
第一作者机构： [1]Shulan (Hangzhou) Hospital Affiliated to Zhejiang, Shuren University Shulan International Medical College, Hangzhou, China. [2]Jinan Microecological Biomedicine Shandong Laboratory, Jinan, China.
共同第一作者：
通讯作者：
通讯机构： [34]Shulan (Hangzhou) Hospital Affiliated to Zhejiang, Shuren University Shulan International Medical College, Hangzhou, China. hainv.gao@shulan.com. [35]Jinan Microecological Biomedicine Shandong Laboratory, Jinan, China. hainv.gao@shulan.com.
推荐引用方式(GB/T 7714)：
Zou Pengfei,Bi Yunjiao,Tong Zhaowei,et al.Comparisons of efficacy and safety of 400 or 800 ml bacterial count fecal microbiota transplantation in the treatment of recurrent hepatic encephalopathy: a multicenter prospective randomized controlled trial in China[J].TRIALS.2024,25(1):doi:10.1186/s13063-024-08578-9.
APA：
Zou Pengfei,Bi Yunjiao,Tong Zhaowei,Wu Tao,Li Qiang...&Gao Hainv.(2024).Comparisons of efficacy and safety of 400 or 800 ml bacterial count fecal microbiota transplantation in the treatment of recurrent hepatic encephalopathy: a multicenter prospective randomized controlled trial in China.TRIALS,25,(1)
MLA：
Zou Pengfei,et al."Comparisons of efficacy and safety of 400 or 800 ml bacterial count fecal microbiota transplantation in the treatment of recurrent hepatic encephalopathy: a multicenter prospective randomized controlled trial in China".TRIALS 25..1(2024)

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