PrEP Users' gut bacteria under the microscope: antibiotic resistance alert
NCT ID NCT07370948
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is checking for antibiotic-resistant bacteria in the gut of 200 people who take PrEP (HIV prevention pills). Researchers will collect rectal swabs during routine STI testing and analyze the bacteria for resistance. The goal is to understand how common resistance is in this group and to help create programs that promote smarter antibiotic use.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this study could lead to better monitoring programs and guidelines for using antibiotics wisely in PrEP users, helping to slow antibiotic resistance.
- What could go wrong
- This is an observational study, not a treatment trial. It only measures resistance patterns and does not test any intervention, so direct health benefits are not expected.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Feb 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
male and female subjects aged between 18 and 45 years who use PrEP and who go to the dedicated clinics of the Infectious Diseases Unit of the IRCCS - University Hospital of Bologna for normal check-ups/follow-ups Patients will be treated in accordance with their normal care process and the results of the study-specific laboratory analyses provided for by this protocol will in no way influence the diagnostic-therapeutic path of the patients.
- Ages
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18 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * age between 18 and 45 years * HIV-negative subjects undergoing an anorectal swab for Chlamydia trachomatis and Neisseria gonorrhoeae using NAAT as a normal diagnostic-assistance procedure provided for subjects using PrEP Exclusion Criteria: * none
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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IRCCS Azienda Ospedaliero-Universitaria di Bologna
RECRUITINGBologna, Bologna, 40138, Italy
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