Paper reading (九十一)：Bifidobacterium breve Bif195 Protects Against Small-Intestinal Damage

论文题目：Bifidobacterium breve Bif195 Protects Against Small-Intestinal Damage Caused by Acetylsalicylic Acid in Healthy Volunteers

scholar 引用：3

页数：14

发表时间：2019.09

发表刊物：Gastroenterology

作者：Mortensen, Brynjulf Murphy, ..., Martin

作者单位：Human Health Innovation, Hoersholm, Denmark

摘要：

Bifidobacterium：双歧杆菌

双歧杆菌属（Bifidobacterium）是一种革兰氏阳性、不运动、细胞呈杆状、一端有时呈分叉状、严格厌氧的细菌属，广泛存在于人和动物的消化道、阴道和口腔等生境中。双歧杆菌属的细菌是人和动物肠道菌群的重要组成成员之一。一些双歧杆菌的菌株可以作为益生菌而用在食品、医药和饲料方面。

双盲实验是指被试和实验者都不知道哪些被试接受哪一处理的实验技术。

Background & Aims
Enteropathy(肠道病) and small-intestinal ulcers(小肠溃疡) are common adverse effects of nonsteroidal(非类固醇的) anti-inflammatory(抗炎的) drugs such as acetylsalicylic(阿司匹林) acid (ASA). Safe, cytoprotective(细胞保护的) strategies are needed to reduce this risk. Specific bifidobacteria(双歧杆菌) might have cytoprotective activities, but little is known about these effects in humans. We used serial video capsule endoscopy(内窥镜检查) (VCE) to assess the efficacy of a specific Bifidobacterium strain in healthy volunteers exposed to ASA.

Methods
We performed a single-site, double-blind, parallel-group, proof-of-concept(单点，双盲，平行组，概念验证) analysis of 75 heathy volunteers given ASA (300 mg) daily for 6 weeks, from July 31 through October 24, 2017. The participants were randomly assigned (1:1) to groups given oral capsules of Bifidobacterium breve (Bif195) (短双歧杆菌Bif195) (≥5 × 1010 colony-forming units) or placebo(安慰剂) daily for 8 weeks. Small-intestinal damage was analyzed by serial VCE at 6 visits. The area under the curve (AUC) for intestinal damage (Lewis score) and the AUC value for ulcers were the primary and first-ranked secondary end points of the trial, respectively.

Results
Efficacy data were obtained from 35 participants given Bif195 and 31 given placebo. The AUC for Lewis score was significantly lower in the Bif195 group (3040 ± 1340 arbitrary units) than the placebo group (4351 ± 3195) (P = .0376). The AUC for ulcer number was significantly lower in the Bif195 group (50.4 ± 53.1 arbitrary units) than in the placebo group (75.2 ± 85.3 arbitrary units) (P = .0258). Twelve adverse events were reported from the Bif195 group and 20 from the placebo group. None of the events was determined to be related to Bif195 intake.

Conclusions
In a randomized, double-blind trial of healthy volunteers, we found oral Bif195 to safely reduce the risk of small-intestinal enteropathy caused by ASA. ClinicalTrials.gov no: NCT03228589.

ClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted around the world.

ClinicalTrials.gov是美国国立医学图书馆(NML)与美国食品与药物管理局(FDA)1997年开发,2002年2月正式运行的临床试验资料库。其主旨有二：①向患者、医疗卫生人员和社会大众提供临床试验信息的查询服务;②向医学科研人员和机构提供临床试验注册服务。 ClinicalTrials.gov是目前国际上最重要的临床试验注册机构之一,其注册和查询临床试验均为免费,被誉为公开化、国际化临床试验注册的典范。

但是看起来这个上面只能看到试验设计吗？不提供数据下载？数据不公开的话，我整理有啥意义呢

①一项双盲随机对照试验中75名健康志愿者分两组，服用8周的短双岐杆菌Bif195或安慰剂，同时前6周服用阿司匹林（ASA）；
②与安慰剂组相比，Bif195组的小肠损伤程度较轻，其肠道损伤和溃疡指数的曲线下面积均显著较低；
③服用ASA后血清PG2和TXB2水平下降，Bif195并未影响该效果，表明Bif195对小肠的保护作用不会干扰ASA的心血管保护功能；
④志愿者的不良反应与Bif195无关；
⑤口服Bif195可安全改善ASA引起的小肠病变。
paper推荐理由：小肠溃疡等肠道病变是阿司匹林等非甾体抗炎药的常见副作用，《Gastroenterology》发表的一项最新益生菌临床试验显示，服用短双歧杆菌Bif195可减轻长期低剂量阿司匹林引起的小肠损伤，具有临床转化应用价值，期待大规模临床试验对此进行验证。
reference：https://www.mr-gut.cn/papers/read/1058386039?kf=read_other

正文组织架构：

1. Introduction

2. Methods

2.1 Study Design

2.2 Participants

2.3 Randomization and Masking

2.4 Procedures

2.5 Outcomes

2.6 Statistical Analysis

3. Results

4. Discussion

正文部分内容摘录：

1. 健康还是特定疾病？多少个体和组别？就是说这些组别的个体是对健康个体进行干预，还是特定疾病的人在干预？

75 heathy volunteers given ASA (300 mg) daily for 6 weeks, from July 31 through October 24, 2017 健康个体总数：75
The participants were randomly assigned (1:1) to groups given oral capsules of Bifidobacterium breve (Bif195) (≥5 × 1010 colony-forming units) or placebo daily for 8 weeks.
Efficacy data were obtained from 35 participants given Bif195 and 31 given placebo. 有效数据个体大概66个，只有9个完全废弃？
Twelve adverse events were reported from the Bif195 group and 20 from the placebo group. None of the events was determined to be related to Bif195 intake. 12+20=32不良案例

2. 有哪些组学数据可利用？

数据没有公布的样子哦

3. 组学数据的下载ID是什么？

4. 研究的干预基本结果和结论是什么？

基本结果：The AUC for Lewis score was significantly lower in the Bif195 group (3040 ± 1340 arbitrary units) than the placebo group (4351 ± 3195) (P = .0376).
基本结果：The AUC for ulcer number was significantly lower in the Bif195 group (50.4 ± 53.1 arbitrary units) than in the placebo group (75.2 ± 85.3 arbitrary units) (P = .0258).
最终结论：In a randomized, double-blind trial of healthy volunteers, we found oral Bif195 to safely reduce the risk of small-intestinal enteropathy caused by ASA.
What You Need to Know
Background and context
Enteropathy and small-intestinal ulcers are common side effects of NSAID such as ASA. There is an unmet need for safe, cytoprotective strategies to reduce this risk.

New findings
Daily, oral intake of Bifidobacteria Bif195 is safe and confers a significant reduced risk of small-intestinal enteropathy caused by acetylsalicylic acid in humans.

Limitations
Longer intervention clinical trials are needed to truly confirm if Bif195 has long-term clinical efficacy in a larger population of chronic users of low-dose acetylsalicylic acid.

Impact
This finding reveals new possibilities to reduce the risk of side effects from acetylsalicylic acid use and make the clinical effect vs side-effect evaluation of low-dose acetylsalicylic acid use in cardiovascular disease prevention more favorable.

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