Effect of Antimicrobial Treatment of Acute Otitis Media on the Intestinal Microbiome in Children: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Change in the relative abundance of Firmicutes in stool samples
研究概览
简要总结
This is a randomized, controlled trial studying the effects of various antimicrobial treatments on the intestinal microbiome of small children. The participating children with acute otitis media are treated wither with amoxicillin, amoxicillin-clavulanate or without antibiotics. The children with allergy to amoxicillin receive a course of macrolide and they will be monitored as a separate group. The main outcomes of this trial are the changes in the intestinal microbiome after the treatment.
详细描述
Antimicrobial treatment of acute otitis media has been proven efficacious in children. It has been suggested that antimicrobial treatment makes a lot of harm to intestinal microbiome and may thus have effects on the child's health and wellbeing. However, data on these changes and their magnitude is scanty. This is a randomized, controlled trial studying the effects of various antimicrobial treatments on the intestinal microbiome of small children. The participating children with acute otitis media are treated wither with amoxicillin, amoxicillin-clavulanate or without antibiotics. The children with allergy to amoxicillin receive a course of macrolide and they will be monitored as a separate group. The main outcomes of this trial are the changes in the intestinal microbiome after the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute symptoms of respiratory infection AND
- •signs of inflammation on the tympanic membrane in otoscopy AND
- •middle ear effusion found in pneumatic otoscopy
排除标准
- •Suspected or proven complication of acute otitis media (for example acute mastoiditis or perforated tympanic membrane)
- •Severe acute otitis media: severe pain and fever > 39 degrees C
- •Bilateral acute otitis media in a child younger than 2 years
- •Primary or secondary immunodeficiency or Downs syndrome
- •Impaired general condition or suspected severe bacterial infection
- •Allergy to both amoxicillin and macrolide
- •Acute otorrhea through tympanostomy tube
- •Antimicrobial treatment ongoing or during previous 7 days
研究组 & 干预措施
Macrolide
The children with acute otitis media with known allergy to amoxicillin or amoxicillin-clavulanate will be treated with macrolide and monitored as a separate group, outside randomization.
干预措施: Macrolide (Drug)
Amoxicillin
The children with acute otitis media will be treated with amoxicillin mixture, 100mg/ml, 40mg/kg/d, divided to two daily doses for 7 days.
干预措施: Amoxicillin (Drug)
Amoxicillin-Potassium Clavulanate
The children with acute otitis media will be treated with amoxicillin-clavulanate mixture, 80mg/ml, 45mg/kg/d, divided to two daily doses for 7 days.
干预措施: Amoxicillin-Potassium Clavulanate (Drug)
结局指标
主要结局
Change in the relative abundance of Firmicutes in stool samples
时间窗: Change from baseline to 10 days
Change in the relative abundance of Firmicutes in stool samples obtained at baseline and at 10 days after the diagnosis of acute otitis media.
次要结局
- Change in the relative abundance of Lactobacilli in stool samples(Change from baseline to 10 days)
- Change in the relative abundance of Actinobacteria in stool samples(Change from baseline to 10 days)
- Change in the relative abundance of Faecalibacterium prausnitzii in stool samples(Change from baseline to 10 days)
- Change in the diversity of fecal microbiota measured with the number of operational taxonomic units (OTUs)(Change from baseline to 10 days)
- Principal coordinate analysis (PCA) of fecal samples(10 days)
- Change in the relative abundance of Bacteroidetes in stool samples(Change from baseline to 10 days)
- Change in the relative abundance of Proteobacteria in stool samples(Change from baseline to 10 days)
- Change in the relative abundance of Verrucomicrobia in stool samples(Change from baseline to 10 days)
- Change in the relative abundance of Bifidobacteria in stool samples(Change from baseline to 10 days)
- Change in the diversity of fecal microbiota measured with Shannon index(Change from baseline to 10 days)
- Change in the diversity of fecal microbiota measured with Chao index(Change from baseline to 10 days)
- Presence of antimicrobial genes measured with the means of metagenomics(10 days)
- Proportion of Clostridium difficile -positive fecal samples(10 days)
- Proportion of fecal samples with Extended Spectrum Beta-Lactamase -positive strains(10 days)