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Could a simple cream prevent painful UTIs in baby boys?

NCT ID NCT07508124

Prevention Sponsor: Baylor College of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 07, 2026 · Updated 2 times

Summary

This pilot study tests whether applying a steroid cream to the foreskin for four weeks can prevent recurrent urinary tract infections (UTIs) in uncircumcised male infants under 6 months who have had their first fever-related UTI. Forty infants will receive either the steroid cream or a placebo. The main goal is to see if a larger study is feasible, not yet to prove the cream works.

What this could mean

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

Active substance
betamethasone valerate 0.1% cream (a steroid cream)
What this could lead to
If this works, it could point toward a simple, non-surgical way to prevent repeat urinary tract infections in uncircumcised baby boys.
What could go wrong
This is a very small pilot study (40 infants) testing the study design, not the treatment's effectiveness. The cream may not reduce infections, and side effects from steroids on sensitive skin are possible.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 40 people

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

Started

May 2026

Expected to finish

Dec 2027

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

0 to 5 months

Sex

Male participants only

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Uncircumcised male infants \< 6 months old 2. Both physician and laboratory confirmed diagnosis of first UTI 3. Fever (temperature ≥38.0 C) or hypothermia (temperature \<36.0 C) per ED/hospitalization or parental report Exclusion Criteria: 1. Legal guardian not available to provide informed consent 2. Infant in Child Protective Services (CPS) custody 3. Legal guardian would like Urology referral for circumcision 4. Circumcision is medically indicated due to recurrent episodes of balanitis or ballooning of foreskin during urination 5. Past diagnosis of penile abnormalities (diagnoses of epispadius, hypospadias or congenital penile curvature (chordee)) 6. Prior use of topical steroid therapy for phimosis 7. History of hypersensitivity to topical steroids 8. Legal guardian is not fluent in English OR Spanish 9. Foreskin assessed to be fully retractable 10. Open wounds present on penis or in groin region

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Conditions

The condition(s) this trial relates to.

urinary tract infection urinary tract infections, recurrent, susceptibility to prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Urinary tract infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Seattle Children's Hospital

    NOT_YET_RECRUITING

    Seattle, Washington, 98105, United States

  • Texas Children's Hospital Main campus

    RECRUITING

    Houston, Texas, 77030, United States

  • Texas Children's Hospital West Campus

    NOT_YET_RECRUITING

    Katy, Texas, 77094, United States

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