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Effect of antifungals on the intestinal microbiome – a randomized, controlled, proof-of-concept trial
EU CTIS ID: 2023-503710-69-00
What this study is testing
to investigate the effect of an antifungal drug (fluconazole) on the intestinal microbiota.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
You likely can't join if
- 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
See the full eligibility criteria
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.