Randomised, double-blind, placebo-controlled trial of Probiotics To Eliminate COVID-19 Transmission in Exposed Household Contacts (PROTECT-EHC): a clinical trial protocol.
Randomised, double-blind, placebo-controlled trial of Probiotics To Eliminate COVID-19 Transmission in Exposed Household Contacts (PROTECT-EHC): a clinical trial protocol.
复制标题
DOI：
10.1136/bmjopen-2020-047069
复制
发表时间：
2021-05-05
期刊：
影响因子：
2.9
通讯作者：
Wischmeyer PE
中科院分区：
文献类型：
--
作者：
Tang H;Bohannon L;Lew M;Jensen D;Jung SH;Zhao A;Sung AD;Wischmeyer PE
COVID-19大流行已被证明是对全球健康的前所未有的挑战，迫切需要采取策略以减轻COVID-19感染的传播和严重程度。新出现的证据表明，肠道微生物组的组成和通过益生菌对微生物生态的改变可以影响对多种感染（包括呼吸道感染）的易感性。在这项研究中，我们的目的是评估益生菌鼠李糖乳杆菌GG（LGG）与安慰剂相比，对COVID-19感染状态和肠道微生物组的影响，这些受试者与家庭接触，COVID-19检测呈阳性。在这项双盲、随机、安慰剂对照试验中，我们将随机分配1132名最近（≤7天）COVID-19检测呈阳性的家庭接触受试者，每日口服LGG或安慰剂，持续28天。我们假设将LGG作为益生菌服用将防止COVID-19感染并降低感染者的疾病严重程度（主要终点：症状减轻），并将与肠道微生物组组成的有益变化相关。将采集粪便样本和鼻拭子，分别通过16 S rRNA测序评估微生物组，并通过PCR评估SARS-CoV-2的存在。我们还将对人口统计学、行为、时间和其他变量进行多变量分析，这些变量可能预测症状的发展和其他结果。本试验是在食品和药物管理局的LGG研究新药下进行的，已获得杜克大学机构审查委员会的伦理批准，并已开始招募。我们计划在同行评审的期刊以及国家和国际会议上传播研究结果。NCT 04399252。
The COVID-19 pandemic has proven to be an unprecedented challenge to worldwide health, and strategies to mitigate the spread and severity of COVID-19 infection are urgently needed. Emerging evidence suggests that the composition of the gut microbiome and modification of microbial ecology via probiotics can affect susceptibility to a wide range of infections, including respiratory tract infections. In this study, we aim to evaluate the effects of the probiotic Lactobacillus rhamnosus GG (LGG) versus placebo on COVID-19 infection status and the gut microbiome in subjects with a household contact who has tested positive for COVID-19. In this double-blinded, randomised, placebo-controlled trial, we will randomise 1132 subjects having a household contact who has recently (≤7 days) tested positive for COVID-19 to daily oral LGG or placebo for 28 days. We hypothesise that taking LGG as a probiotic will protect against COVID-19 infection and reduce the severity of disease in those who become infected (primary endpoint: decreased symptoms), and will be associated with beneficial changes in the composition of the gut microbiome. Stool samples and nasal swabs will be collected to evaluate the microbiome by 16S rRNA sequencing and the presence of SARS-CoV-2 by PCR, respectively. We will also conduct multivariate analysis of demographic, behavioural, temporal, and other variables that may predict development of symptoms and other outcomes. This trial is conducted under a Food and Drug Administration Investigational New Drug for LGG, has received ethics approval by the institutional review board of Duke University and enrolment has begun. We plan to disseminate the results in peer-reviewed journals and at national and international conferences. NCT04399252.
登录
查看更多内容
影响因子：
6.7
作者：
Neill DR;Fernandes VE;Wisby L;Haynes AR;Ferreira DM;Laher A;Strickland N;Gordon SB;Denny P;Kadioglu A;Andrew PW
通讯作者：
Andrew PW
影响因子：
4.6
作者：
Kiso, Maki;Takano, Ryo;Sakabe, Saori;Katsura, Hiroaki;Shinya, Kyoko;Uraki, Ryuta;Watanabe, Shinji;Saito, Hiroshi;Toba, Masamichi;Kohda, Noriyuki;Kawaoka, Yoshihiro
通讯作者：
Kawaoka, Yoshihiro
DOI：
10.1186/s13054-016-1434-y
发表时间：
2016-08-19
期刊：
Critical care (London, England)
影响因子：
--
作者：
Manzanares W;Lemieux M;Langlois PL;Wischmeyer PE
通讯作者：
Wischmeyer PE
DOI：
10.1097/shk.0000000000000066
发表时间：
2013-12
期刊：
Shock (Augusta, Ga.)
影响因子：
--
作者：
Khailova L;Baird CH;Rush AA;McNamee EN;Wischmeyer PE
通讯作者：
Wischmeyer PE
影响因子：
64.8
作者：
Panigrahi, Pinaki;Parida, Sailajanandan;Gewolb, Ira H.
通讯作者：
Gewolb, Ira H.