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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503710-69-00
Enrollment
50
Registered
2023-07-14
Start date
2026-01-05
Completion date
Unknown
Last updated
2025-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Not applicable - Healthy Volunteer study

Brief summary

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).

Detailed description

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

Interventions

DRUGFluconazol Teva 200 mg

Sponsors

Amsterdam UMC
Lead SponsorOTHER

Eligibility

Sex/Gender
Male
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
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).

Secondary

MeasureTime frame
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

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026