亲爱的研友该休息了!由于当前在线用户较少,发布求助请尽量完整地填写文献信息,科研通机器人24小时在线,伴您度过漫漫科研夜!身体可是革命的本钱,早点休息,好梦!

Multidonor intensive faecal microbiota transplantation for active ulcerative colitis: a randomised placebo-controlled trial

溃疡性结肠炎 医学 安慰剂 内科学 随机对照试验 胃肠病学 结肠镜检查 灌肠 临床试验 移植 结直肠癌 疾病 病理 癌症 替代医学
作者
Sudarshan Paramsothy,Michael A. Kamm,Nadeem O. Kaakoush,Alissa Walsh,Johan van den Bogaerde,Douglas Samuel,Rupert W. Leong,Susan J. Connor,Watson Ng,Ramesh Paramsothy,Wei Xuan,Enmoore Lin,Hazel M. Mitchell,Thomas J. Borody
出处
期刊:The Lancet [Elsevier BV]
卷期号:389 (10075): 1218-1228 被引量:1067
标识
DOI:10.1016/s0140-6736(17)30182-4
摘要

Summary

Background

The intestinal microbiota is implicated in the pathogenesis of ulcerative colitis. Faecal microbiota transplantation is a novel form of therapeutic microbial manipulation, but its efficacy in ulcerative colitis is uncertain. We aimed to establish the efficacy of intensive-dosing, multidonor, faecal microbiota transplantation in active ulcerative colitis.

Methods

We conducted a multicentre, double-blind, randomised, placebo-controlled trial at three hospitals in Australia. We randomly allocated patients with active ulcerative colitis (Mayo score 4–10) in a 1:1 ratio, using a pre-established randomisation list, to either faecal microbiota transplantation or placebo colonoscopic infusion, followed by enemas 5 days per week for 8 weeks. Patients, treating clinicians, and other study staff were unaware of the assigned treatment. Faecal microbiota transplantation enemas were each derived from between three and seven unrelated donors. The primary outcome was steroid-free clinical remission with endoscopic remission or response (Mayo score ≤2, all subscores ≤1, and ≥1 point reduction in endoscopy subscore) at week 8. Analysis was by modified intention-to-treat and included all patients receiving one study dose. We performed 16S rRNA stool analysis to assess associated microbial changes. This trial is registered with ClinicalTrials.gov, number NCT01896635. The trial has ended; this report presents the final analysis.

Findings

From November, 2013, to May, 2015, 85 patients were enrolled to our trial, of whom 42 were randomly assigned faecal microbiota transplantation and 43 were allocated placebo. One patient assigned faecal microbiota transplantation and three allocated placebo did not receive study treatment and were excluded from the analysis. The primary outcome was achieved in 11 (27%) of 41 patients allocated faecal microbiota transplantation versus three (8%) of 40 who were assigned placebo (risk ratio 3·6, 95% CI 1·1–11·9; p=0·021). Adverse events were reported by 32 (78%) of 41 patients allocated faecal microbiota transplantation and 33 (83%) of 40 who were assigned placebo; most were self-limiting gastrointestinal complaints, with no significant difference in number or type of adverse events between treatment groups. Serious adverse events occurred in two patients assigned faecal microbiota transplantation and in one allocated placebo. Microbial diversity increased with and persisted after faecal microbiota transplantation. Several bacterial taxa were associated with clinical outcome; in particular, the presence of Fusobacterium spp was associated with lack of remission.

Interpretation

Intensive-dosing, multidonor, faecal microbiota transplantation induces clinical remission and endoscopic improvement in active ulcerative colitis and is associated with distinct microbial changes that relate to outcome. Faecal microbiota transplantation is, thus, a promising new therapeutic option for ulcerative colitis. Future work should focus on precisely defining the optimum treatment intensity and the role of donor–recipient matching based on microbial profiles.

Funding

Broad Medical Research Program, Gastroenterological Society of Australia, Mount Sinai (New York) SUCCESS fund, University of New South Wales.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
852应助scholar丨崔采纳,获得10
13秒前
14秒前
一D完成签到,获得积分10
17秒前
儒雅致远发布了新的文献求助10
20秒前
YiPeng完成签到,获得积分10
21秒前
24秒前
核桃发布了新的文献求助10
29秒前
桐桐应助儒雅致远采纳,获得10
30秒前
核桃完成签到,获得积分0
34秒前
排骨大王完成签到,获得积分10
35秒前
36秒前
joker完成签到 ,获得积分10
40秒前
核桃发布了新的文献求助100
43秒前
47秒前
温暖元容完成签到,获得积分10
50秒前
scholar丨崔发布了新的文献求助10
54秒前
1分钟前
淡定的彩虹完成签到,获得积分10
1分钟前
1分钟前
sss发布了新的文献求助10
1分钟前
1分钟前
情怀应助科研通管家采纳,获得10
1分钟前
1分钟前
卡卡完成签到 ,获得积分10
1分钟前
CNY完成签到 ,获得积分10
1分钟前
赘婿应助_ban采纳,获得10
1分钟前
2分钟前
bksqc发布了新的文献求助10
2分钟前
bksqc完成签到,获得积分10
2分钟前
卑微学术人完成签到 ,获得积分10
2分钟前
2分钟前
无花果应助feifei采纳,获得10
2分钟前
griffon完成签到,获得积分10
3分钟前
汉堡包应助通通采纳,获得10
3分钟前
3分钟前
Huay完成签到 ,获得积分10
3分钟前
tingting9发布了新的文献求助10
3分钟前
英俊的铭应助科研通管家采纳,获得10
3分钟前
3分钟前
kd1412应助科研通管家采纳,获得10
3分钟前
高分求助中
The Mother of All Tableaux: Order, Equivalence, and Geometry in the Large-scale Structure of Optimality Theory 3000
A new approach to the extrapolation of accelerated life test data 1000
ACSM’s Guidelines for Exercise Testing and Prescription, 12th edition 500
Indomethacinのヒトにおける経皮吸収 400
Phylogenetic study of the order Polydesmida (Myriapoda: Diplopoda) 370
基于可调谐半导体激光吸收光谱技术泄漏气体检测系统的研究 350
Robot-supported joining of reinforcement textiles with one-sided sewing heads 320
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 3990020
求助须知:如何正确求助?哪些是违规求助? 3532077
关于积分的说明 11256276
捐赠科研通 3270943
什么是DOI,文献DOI怎么找? 1805139
邀请新用户注册赠送积分活动 882270
科研通“疑难数据库(出版商)”最低求助积分说明 809228