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
Year: 2024
Type: article
Abstract: BACKGROUND: 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. METHODS: 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. DISCUSSION: 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. TRIAL REGISTRATION: NCT05669651 on ClinicalTrials.gov. Registered on 29 December 2022. CHiCTR2200067135 on China Registered Clinical Trial Registration Center. Registered on 27 December 2022.
Source: Trials
Authors: Pengfei Zou, Yunjiao Bi, Zhaowei Tong, Tao Wu, Qiang Li, Kai Wang, Yuchen Fan, Dan Zhao, Xin Wang, Hui Shao, Haijun Huang, Suping Ma, Yunsong Qian, Guoqiang Zhang, Xiao Liu, Qiaofei Jin, Qingjing Ru, Zhiping Qian, Wei Sun, Qiang Chen, Liying You, Fang Wang, Xiaoting Zhang, ZhenXiong Qiu, Qing Lin, Jiaojian Lv, Yongping Zhang, Jiawei Geng, Richeng Mao, Jinfeng Liu, Yubao Zheng, Feng Ding, Hui Wang, Hainv Gao
Institutions: Zhejiang Shuren University, Zhejiang Chinese Medical University, Huzhou Central Hospital, Hainan General Hospital, Shandong University, Qilu Hospital of Shandong University, Zhejiang Provincial People's Hospital, Henan University, First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Ningbo No. 2 Hospital, Luoyang Central Hospital Affiliated to Zhengzhou University, Hangzhou Xixi hospital, Zhejiang University, Shanghai Public Health Clinical Center, First Affiliated Hospital of Soochow University, Binzhou People's Hospital, The First Hospital of Kunming, Zoucheng People's Hospital, Shenzhen Bao'an District Songgang People's Hospital, Chongqing Jiulongpo People's Hospital, Lishui City People's Hospital, People's Hospital of Xinjiang Uygur Autonomous Region, Kunming University of Science and Technology, First People's Hospital of Yunnan Province, Fudan University, Huashan Hospital, First Affiliated Hospital of Xi'an Jiaotong University, Third Affiliated Hospital of Sun Yat-sen University, Shaoxing University, Shanghai Jiao Tong University, Ruijin Hospital
Language: English
Subfield: Hepatology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,590
Award: G4317767458
OpenAlex ID: W4404764644