Kuwelker Kanika, Langeland Nina, Löhr Iren Høyland, Gidion Joshua, Manyahi Joel, Moyo Sabrina John, Blomberg Bjørn, Klingenberg Claus
Norwegian National Advisory Unit on Tropical Infectious Diseases, Haukeland University Hospital, Haukelandsbakken, 5009, Bergen, Norway.
Department of Clinical Science, University of Bergen, Laboratory Building, Haukeland University Hospital, Jonas Lies veg 87, 5021, Bergen, Norway.
Trials. 2021 Apr 29;22(1):312. doi: 10.1186/s13063-021-05251-3.
Extended-spectrum beta-lactamase-producing Enterobacteriaceae (ESBL-E) has emerged as an urgent global health threat and is by the World Health Organization ranked as priority 1 among pathogens in need of new treatment. Studies have shown high mortality in Tanzanian children with ESBL-E infections. Gut colonization of ESBL-E, which is a potential risk factor of ESBL-E infections, is reported to be very high among children in Tanzania. Probiotics may potentially reduce gut colonization of multidrug-resistant bacteria. However, there is limited data on whether probiotics may reduce ESBL-E carriage in infants. The ProRIDE Trial aims to evaluate whether the use of probiotics can reduce morbidity and mortality among infants in Haydom, Tanzania, and whether this effect is associated with a reduction in ESBL-E colonization and/or infections.
METHODS/DESIGN: This large randomized double-blinded placebo-controlled trial aims to recruit 2000 newborn infants at Haydom Lutheran Hospital and the surrounding area in the period of November 2020 to November 2021. Participants will be enrolled from days 0 to 3 after birth and randomized to receive probiotics or placebo for 4 weeks. Participants will be followed-up for 6 months, during which three visits will be made to collect clinical and demographic information, as well as rectal swabs and fecal samples which will be subjected to laboratory analysis. The primary composite outcome is the prevalence of death and/or hospitalization at 6 months of age.
As the use of probiotics may give a more favorable gut composition, and thereby improve health and reduce morbidity and mortality, the results may have implications for future therapy guidelines in Africa and internationally.
ClinicalTrials.gov NCT04172012. Registered on November 21, 2019.
产超广谱β-内酰胺酶肠杆菌科细菌（ESBL-E）已成为全球紧迫的健康威胁，世界卫生组织将其列为急需新型治疗的病原体中的首要重点。研究表明，坦桑尼亚感染ESBL-E的儿童死亡率很高。据报道，ESBL-E的肠道定植是ESBL-E感染的一个潜在危险因素，在坦桑尼亚儿童中非常普遍。益生菌可能会减少多重耐药菌的肠道定植。然而，关于益生菌是否能减少婴儿携带ESBL-E的数据有限。益生菌降低婴幼儿感染风险试验（ProRIDE试验）旨在评估使用益生菌是否能降低坦桑尼亚海多姆地区婴儿的发病率和死亡率，以及这种效果是否与ESBL-E定植和/或感染的减少有关。
方法/设计：这项大型随机双盲安慰剂对照试验旨在在2020年11月至2021年11月期间，从海多姆路德医院及周边地区招募2000名新生儿。参与者将在出生后0至3天入组，并随机接受益生菌或安慰剂治疗4周。参与者将接受6个月的随访，在此期间将进行三次访视，以收集临床和人口统计学信息，以及直肠拭子和粪便样本，这些样本将进行实验室分析。主要复合结局是6个月龄时的死亡和/或住院患病率。
由于使用益生菌可能会使肠道菌群组成更有利，从而改善健康状况并降低发病率和死亡率，该结果可能会对非洲及国际未来的治疗指南产生影响。
ClinicalTrials.gov NCT04172012。于2019年11月21日注册。
