NCT07425704尚未招募不适用
Probiotics, Antibiotics and the Post-Antibiotic Microbiota
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Cultech Ltd
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Changes in microbiome composition post antibiotic/interventional treatment through Shotgun Metagenomics
研究概览
简要总结
Antibiotic therapy can cause gastrointestinal dysbiosis and this study will assess the impact of probiotic supplementation on microbiological composition and functionality pre- and post- antibiotic therapy
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults, aged 18-
- •Been prescribed an oral dose of cephalosporin antibiotic lasting 5 - 10 days.
- •Willing to provide stool samples and, for women, vaginal samples.
- •Willing to avoid consumption of any other probiotic capsules/tablets during the study.
排除标准
- •If antibiotics prescribed are intended to treat any gastrointestinal or vaginally related issue.
- •Any antibiotic intake within the last 3 months.
- •Immunodeficient or undergoing immunosuppressive therapy.
- •Currently diagnosed with diabetes/cardiovascular disease/cancer/dementia.
- •Any unexplained loss of weight in recent months.
- •Known to be pregnant or <3 months postpartum.
研究组 & 干预措施
Active
Active Comparator
Probiotic containing lactic acid bacteria and Saccharomyces boulardii at a dose of 35 billion per day
干预措施: Lab4S (Dietary Supplement)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Changes in microbiome composition post antibiotic/interventional treatment through Shotgun Metagenomics
时间窗: From date of randomization until the end of the study (90 days)
次要结局
- Questionnaire of gastrointestinal/Vaginal health to measure gastrointestinal/vaginal health post intervention.(One month post antibiotic treatment/ intervention (30 days))
- Bowel habit diary to measure gastrointestinal health post Intervention(One month post antibiotic treatment/ intervention (30 days))
研究者
研究点 (1)
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