Can cleaning up the penile microbiome stop bacterial vaginosis from coming back?

NCT ID NCT05963711

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Recruiting now This study
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Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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Running, but no longer taking on new participants.
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The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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First seen Sep 23, 2026 · Last updated Sep 24, 2026 · Updated 1 time

Summary

Researchers are studying the penile microbiome of male partners of women with recurrent bacterial vaginosis (BV) to see whether BV-linked bacteria live on the penis and whether a cleaning routine can remove them. About 100 men whose female partners are enrolled in a vaginal microbiota transplant study will provide samples. If BV-associated bacteria are found, men will wash daily with a chlorhexidine gluconate 4% solution for five days, and if needed, apply a 2% clindamycin cream to the penis. The study measures changes in the penile microbiome after this decolonization attempt.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a chlorhexidine gluconate 4% wash followed by topical 2% clindamycin cream
What this could lead to
If the washing and antibiotic routine clears BV-linked bacteria from male partners, it could point to a way to lower the chance that bacterial vaginosis comes back in women.
What could go wrong
The study is small and observational in part, so it may not show that clearing penile bacteria prevents recurrence. The wash and antibiotic cream can irritate the skin, and some bacteria may survive the routine.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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: * The subject has s female partner who participates in VMT study ( NCT04517487). * The subject is defined by the woman as her male regular partner. * Willing to use a condom as instructed by the protocol. * Willing to comply with decolonization protocol. Exclusion Criteria: * A known skin disease involving the penile skin. * A known sensitivity to chlorhexidine gluconate * Any of the partners (female/male) has more than one sexual partner.

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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

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Contacts and locations

Locations

  • Hadassah Medical Center

    RECRUITING

    Jerusalem, Israel

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