The goal of this clinical trial is to learn how the antifungal drug fluconazole affects the gut microbiome and immune system in healthy volunteers.
The main questions it aims to answer are:
* Does fluconazole change the gut bacteriome and mycobiome composition after 14 days of treatment? * How long do these changes last (4 weeks and 6 months after treatment)? * Does fluconazole affect the body's immune responses, such as blood cell activity and antifungal antibodies?
Researchers will compare two groups: participants who take fluconazole for 14 days and participants who receive no intervention.
Participants will:
* Either take one fluconazole tablet (200 mg) daily for 14 days, or receive no treatment * Provide stool samples and blood samples at several timepoints * Return for follow-up visits up to 6 months after treatment
This study is conducted at Amsterdam UMC, location AMC, with a planned enrollment of 50 healthy male volunteers aged 18-35 years.
Male, 18-35 years of age at the time of signing informed consent
Healthy, as determined by medical history and physical examination; minor clinical abnormalities allowed if not introducing additional risk or interfering with study procedures
Capable of giving written informed consent and able to comply with study requirements
Normal defecation pattern (≤3 times/day and ≥3 times/week)
Major illness in the past 3 months, or significant chronic medical illness deemed unfavorable for enrollment
Past or current gastrointestinal disease that may influence the gut microbiota (including inflammatory bowel disease or medication-treated irritable bowel syndrome)
History of immunodeficiency
History of malignancy
Parallel
Fluconazole 200mg tab
DrugOral administration of one 200 mg fluconazole tablet once daily for 14 days.
Effect of fluconazole on the intestinal microbiome
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).
Gut microbiome and mycobiome composition at 6 months post-treatment
Differences in gut bacteriome and mycobiome composition, including α- and β diversity, between fluconazole and no-intervention arms and compared to baseline, 6 months after completion of fluconazole treatment.
Gut microbial functional profiles after fluconazole treatment
Differences in gut microbial functional profiles, including metabolic pathways and in vitro fecal microbial fermentation, between fluconazole and no-intervention arms
Systemic innate immune responses after fluconazole treatment
Differences in host systemic innate immune response profiles between fluconazole and no-intervention arms at baseline, 14 days, 4 weeks, and 6 months. Responses will be assessed using ex vivo stimulation assays of peripheral blood mononuclear cells and neutrophils, and measurement of antifungal antibodies.
Click on the lead sponsor to view all of their trials.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
