Topical Steroids to Prevent Recurrent Urinary Tract Infections in Uncircumcised Male Infants: a Pilot Study

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT07508124
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Urinary Tract Infection

Eligibility Criteria

Sex
MALE
Age
0 Months - 5 Months
Healthy Volunteers
Not accepted

Interventions

  • betamethasone valerate 0.1% cream — DRUG
    Steroid cream applied to the foreskin and glans twice a day for four weeks.
  • Placebo cream — DRUG
    Placebo cream is applied to the foreskin and glans twice a day for four weeks.

Study Details

The goal of this smaller clinical trial is to evaluate the study design of this research to help prepare for a larger research study in the future. The future larger study would focus on whether steroid cream can reduce recurrent urinary tract infections in male infants, who are not circumcised. Male infants, who are enrolled in this study, would receive either the steroid cream or a placebo cream (a look alike cream without steroids). The cream would be applied twice a week for four weeks. Then there would be two follow up visits with the research team to measure whether the infant experienced any urinary tract infections and to measure parent perceptions of their experience participating in the study.

Key Dates

Start date
Apr 30, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Participants randomized to receive steroid cream
  • Placebo Comparator: Participants randomized to receive placebo cream.

Primary Outcome Measure

Feasibility of recruitment across different settings [ Time Frame: up to 2 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Texas Children's Hospital Main campusHoustonTexas77030
Sowdhamini Wallace, DO, MS
[email protected]
832-824-5447
Sowdhamini Wallace, DO, MS (PRINCIPAL_INVESTIGATOR)
Grace Truong, MD (SUB_INVESTIGATOR)
Chester Koh, MD, MBA (SUB_INVESTIGATOR)
Jaqueline Broda, MPAS, PA-C (SUB_INVESTIGATOR)
Saamia Masoom, MD (SUB_INVESTIGATOR)
Texas Children's Hospital West CampusKatyTexas77094
Sowdhamini Wallace, DO, MS
[email protected]
832-824-5447
Sowdhamini Wallace, DO, MS (PRINCIPAL_INVESTIGATOR)
Marina Bishai, DO (SUB_INVESTIGATOR)
Seattle Children's HospitalSeattleWashington98105
Eric Coon, MD, MS
[email protected]
Eric Coon, MD, MS (PRINCIPAL_INVESTIGATOR)

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By research site
Texas Children's Hospital Main campus· Houston, TXTexas Children's Hospital West Campus· Katy, TXSeattle Children's Hospital· Seattle, WA

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