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临床试验/NCT03587545
NCT03587545Unknown不适用

Study of Probiotic Potential of Nasopharyngeal Lactobacillus Strains in the Upper Respiratory Tract After Nasal Spray Application

University Hospital, Antwerp2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
试验地点
2
主要终点
Nasal persistence of lactobacilli

研究概览

简要总结

Probiotics are defined as "live micro-organisms that, when administered in adequate amounts, confer a health benefit to the host" (Hill et al, 2014). These microbes are generally applied in the gastrointestinal tract via fermented food products or capsules. In previous research, the investigators isolated bacterial strains with potential probiotic properties for the upper respiratory tract based on in vitro laboratory tests, in vivo mice experiments and genome sequencing.

In this study, the investigators want to deliver the Proof-of-Concept that the most promising isolated strain, Lactobacillus casei AMBR2 (LAMBR2) and the well-documented probiotic strain Lactobacillus rhamnosus GG (LGG) also have interesting properties in humans, i.e. that these strains are able to -temporarily- persist in the upper respiratory tract of healthy volunteers and CRS patients after daily nasal application via a nasal spray for 2 weeks. In addition, the investigators aim to explore whether the application of these strains has an impact on the nasopharyngeal microbiome via 16S rRNA amplicon sequencing and dedicated qPCR analysis.

Therefore, bacterial DNA from nasal swabs will be isolated via commercially available DNA extraction kits, followed by Illumina MiSeq sequencing in order to identify the bacterial species present in these samples. Furthermore, the concentration of the Lactobacillus and specific pathogens will be monitored via qPCR.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • CRS patient group: CRS diagnosed

排除标准

  • no patients with trisomy 21
  • no pregnant women
  • no breastfeeding women
  • no acute or chronic airway infections (except for CRS patients in CRS patient group)
  • no cancer
  • no autoimmune diseases

结局指标

主要结局

Nasal persistence of lactobacilli

时间窗: 3 years

After DNA extraction of the biological samples, the relative and absolute concentration of the administered probiotics will be monitored via microbiome analysis and qPCR. This will give information about the capacity of the probiotics to colonize the nasopharynx.

次要结局

  • Therapeutic potential: chronic rhinosinusitis(3 years)
  • Microbiome differences(3 years)
  • Therapeutic potential: nasal hyperreactivity(3 years)
  • Therapeutic potential: SNOT-22 score(3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ethisch Comité, UZA

Principal Investigator

University Hospital, Antwerp

研究点 (2)

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