Effect of antifungals on the intestinal microbiome – a randomized, controlled, proof-of-concept trial

Amsterdam UMC0 个研究点目标入组 50 人开始时间: 2023年4月11日最近更新: 2024年7月22日

适应症

试验速览

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•Male, 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)

•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

发起方

Amsterdam UMC