2023-503710-69-00招募中4 期
Effect of antifungals on the intestinal microbiome – a randomized, controlled, proof-of-concept trial
Amsterdam UMC1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年7月14日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Difference in gut bacteriome and mycobiome composition, ⍺- and ß-diversity between adults treated with an antifungal (fluconazole) and no intervention directly after completion of antifungal treatment (t=14 days).
研究概览
简要总结
to investigate the effect of an antifungal drug (fluconazole) on the intestinal microbiota.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •18-35 years of age at the time of signing the informed consent
- •Healthy, as determined by a responsible physician, based on a medical evaluation including medical history and physical examination. A subject with a clinical abnormality may be included if the investigator agrees that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures
- •Capable of giving written informed consent and able to comply with the requirements and restrictions listed in the informed consent form
- •Normal defecation pattern (defined as ≤3x/ day and ≥3x/week)
排除标准
- •Subject has had a major illness in the past 3 months or any significant chronic medical illness that the investigator would deem unfavourable for enrolment
- •The subject has received an investigational product within three months of day 0 of the current study
- •Use of prescription or non-prescription drugs and herbal and dietary supplements within 3 months unless in the opinion of the investigator the medication will not interfere with the study procedures or compromise subject safety
- •Subject has difficulty in donating blood or accessibility of a vein in left or right arm
- •Subject has donated more than 500 mL of blood in last 3 months
- •Any other issue that, in the opinion of the investigator, could be harmful to the subject or compromise interpretation of the data
- •Subject has a past or current gastrointestinal disease which may influence the gut microbiota, including inflammatory bowel disease and medication-treated irritable bowel syndrome
- •Subject with any history of immunodeficiency
- •Subject with a history of any type of malignancy
- •Drinking more than an average of 3 units of alcohol per day
- •Known allergy to antifungals (any kind)
- •Recent (< 3 months) use of antibiotics (any kind, except for dermal antibiotics)
- •Recent (< 3 months) use of antifungals (any kind, except for dermal antifungals)
- •Planned prolonged (> 4 weeks) travel to tropical countries during the study period
结局指标
主要结局
Difference in gut bacteriome and mycobiome composition, ⍺- and ß-diversity between adults treated with an antifungal (fluconazole) and no intervention directly after completion of antifungal treatment (t=14 days).
Difference in gut bacteriome and mycobiome composition, ⍺- and ß-diversity between adults treated with an antifungal (fluconazole) and no intervention directly after completion of antifungal treatment (t=14 days).
次要结局
- Differences in gut bacteriome and mycobiome composition, ⍺- and ß-diversity between arms and compared to baseline, at 4 weeks after completion of fluconazole treatment, and at 6 months
- Differences in gut microbial functional profiles (in the form of metabolic pathways and in vitro faecal microbial fermentation) between arms at the different timepoints
- Differences in host systemic innate immune response profiles between arms at the different timepoints. Characterized by, amongst others, ex vivo stimulation assays of peripheral blood mononuclear cells and neutrophils, and measurement of antifungal antibodies
研究者
W.J. Wiersinga
Scientific
Amsterdam UMC
研究点 (1)
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