Effect of Saccharomyces Boulardii CNCM I-745 on Antibiotic-perturbed Microbiota in Children: RESTORE STUDY
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Change in intestinal microbiota bacteria composition
研究概览
简要总结
This study aims to evaluate the effect of co-administering the probiotic Saccharomyces boulardii CNCM I-745 with amoxicillin-clavulanic acid on the intestinal and nasopharyngeal microbiota in children diagnosed with acute otitis media or acute bacterial sinusitis. The trial will also assess the potential of the probiotic to reduce antibiotic-associated diarrhea (AAD), antibiotic associated microbiota perturbation, and the spread of antibiotic resistance genes (ARGs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Microbiota analysis will be blinded
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed with acute otitis medica or acute rhinosinusitis
- •No chronic diseases or recent antibiotic/probiotic use (past 8 weeks)
- •Parental consent obtained
排除标准
- •Age <4 or >12 years
- •Chronic illness or GI disorders
- •History of antibiotic allergy or immunocompromise
- •Malnutrition or obesity
- •Recent gastrointestinal surgery
研究组 & 干预措施
Antibiotic-Only Group
Amoxicillin-clavulanic acid for 10 days (no probiotic)
干预措施: Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension (Drug)
Probiotic 10 Days Group
Amoxicillin-clavulanic acid + S. boulardii for 10 days
干预措施: Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension (Drug)
Probiotic 10 Days Group
Amoxicillin-clavulanic acid + S. boulardii for 10 days
干预措施: Saccharomyces boulardii CNCM I-745 (Dietary Supplement)
Healthy Control Group
No infection, antibiotics, or probiotics
Probiotic 21 Days Group
Amoxicillin-clavulanic acid for 10 days + S. boulardii for 21 days (overlapping first 10 days)
干预措施: Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension (Drug)
Probiotic 21 Days Group
Amoxicillin-clavulanic acid for 10 days + S. boulardii for 21 days (overlapping first 10 days)
干预措施: Saccharomyces boulardii CNCM I-745 (Dietary Supplement)
结局指标
主要结局
Change in intestinal microbiota bacteria composition
时间窗: 0, 10, 21 and 56 days
Change in intestinal microbiota bacteria composition with WGS
Potential changes in antibiotic resistant genes (ARGs)
时间窗: 0, 10, 21, and 56 days of study
Potential changes in antibiotic resistant genes (ARGs)
次要结局
- Change in intestinal microbiota virome composition(0, 10, 14, 56 days of study)
- Change in intestinal microbiota mycobiome composition(0, 10, 14, 21 days of study)
- Changes in nasopharyngeal microbiota composition(0, 10, 21, 56 days of intervention)
研究者
Ener Cagri DINLEYICI
Professor in Pediatrics
Eskisehir Osmangazi University