An Early Phase 1 interventional study of Bactrim DS 800Mg-160Mg Tablet and Placebo oral tablet in Microtia, UTI and Bacteriuria, sponsored by Johns Hopkins University. Withdrawn. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-03.
Sponsored by Johns Hopkins University · Early Phase 1, Interventional, and Basic science
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.
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.
33 studies on the registry are indexed under Congenital Microtia; 10 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be recruited and enrolled. Participants will be surveyed regarding environmental, health, and behavioral practices. (Instrument 1) . Then a clean catch urine specimen will be collected. Participants will be provided with placebo to be taken twice daily. This will be considered day 0. Participants will then be instructed to take the study drug twice daily and return on Day 2, Day 5, Day 10, Day 30, and Day 180 for additional clean-catch urine specimen.
Drug: Placebo oral tablet
Participants will be recruited and enrolled. Participants will be surveyed regarding environmental, health, and behavioral practices. (Instrument 1) . Then a clean catch urine specimen will be collected. Participants will be provided with Bactrim 800/120 to take twice daily. This will be considered day 0. Participants will then be instructed to take the study drug twice daily and return on Day 2, Day 5, Day 10, Day 30, and Day 180 for additional clean-catch urine specimen.
Drug: Bactrim DS 800Mg-160Mg Tablet
To study effect on urinary microbiome
Also known as: bactrim, trimethoprim sulfamethoxazole, Septra, sulfatrim
To study effect on urinary microbiome
Change in Microbiome flora number of organisms
Analysis of 16S rRNA gene amplicon data to determine number of varied organisms (genus and species).
Time frame: At Baseline, Day 2, Day 5, Day 10, Day 30, and Day 180 of study
Change in Microbiome flora percentage distribution of organisms
Analysis of 16S rRNA gene amplicon data to determine the percent distribution of organisms (microbiologic genus and species).
Time frame: At Baseline, Day 2, Day 5, Day 10, Day 30, and Day 180 of study
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2023; primary completion for Feb 2025, 16 months later.
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This study is withdrawn, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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