Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT04230746 |
| Other study ID # |
IRB00224835 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
Early Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
October 2023 |
| Est. completion date |
February 2026 |
Study information
| Verified date |
October 2021 |
| Source |
Johns Hopkins University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Planning to study urine microbiota at baseline and after administration of bactrim
antibiotics in healthy volunteers. Will intermittently collect voided urine specimens for 16
s DNA analysis over a period of 6 months after 2 weeks of bactrim or placebo.
Description:
Urinary tract infections (UTI) are the most common type of human bacterial disease, prompting
more than 10 million physician office visits annually at a healthcare cost of over $1 billion
dollars. Treatment of UTI is typically empiric or culture-driven antibiotics which are
associated with ever increasing bacterial resistance. Over the last decade, The Human
Microbiome Project has established that even 'culture-negative' urine represents a diverse
ecosystem of bacteria. Despite broad use of antibiotics to cure disease for the past 90
years, the broader impact of antibiotics on typical flora are not well understood.
Antibiotics are also commonly used as prophylaxis for surgical procedures in the urinary
tract altering patient outcomes in unforeseen ways. Despite widespread utilization of
antibiotics, the longitudinal impact on the dynamic intravesical environment remains
completely unknown.
Dysbiosis in the microbiome has been suggested as a causative agent in a wide range of
disease: arthritis, metabolic disorders, neurologic disease, inflammatory bowel conditions,
and cancer. Yet there remains a fundamental knowledge gap regarding the short and long-term
effect of antibiotics on microbiota communities. Specifically within the urinary tract,
variance in baseline commensal organisms have been associated with interstitial cystitis,
overactive bladder, frequent symptomatic urinary tract infection and potentially cancer
development. The study of microbiota reveal pathways and mechanisms that play important roles
in immunological response and health but studies typically are limited to the gut.
To address this knowledge gap, the investigators plan a placebo controlled randomized trial
to test the longitudinal impact of 10 days of trimethoprim-sulfamethoxazole on the urinary
microbiome in healthy adults. Data collection for individual participants will persist for a
period of 6 months. The investigators hypothesize antibiotic administration contributes to a
rise in bacterial resistance and directly leads to urine microbiome dysbiosis. The
investigators further hypothesize the urinary microbiome does not return to baseline, with
loss of certain bacteria permanent during the study period. While the investigators' study is
groundbreaking and novel, the feasibility of the investigators' experimental plan has been
previously demonstrated in the study of the salivary and gut microbiome. Ultimately the
investigators anticipate even a single course of antibiotic treatment may increase the risk
of bacterial resistance and lead to long-lasting shifts in the urinary microbiome. If
confirmed, this knowledge will directly influence clinical decision making in antibiotic
selection, duration, and utility.
