MicrotiaEarly Phase 1NCT04230746
Effect of Antibiotics on Urinary Microbiome
A Early Phase 1 study testing Bactrim DS 800Mg-160Mg Tablet in people with Microtia and UTI, run by Johns Hopkins University.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Microtia, UTI, Bacteriuria
- What is being tested?
- Bactrim DS 800Mg-160Mg Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Feb 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Diagnosed or suspected urinary tract infection in prior 6 months
- Treated with antibiotics for any reason in prior 6 months
- Allergy to sulfa
- Under 18
- Pregnant or planning to become pregnant in the next 12 months by self report (as is the clinical standard for prescribing this medication for suspected or proven UTI treatment)
- Use indwelling or intermittent urinary hardware or implant such as supra-pubic tube or catheter
Show all 17Show fewer
- Neurogenic bladder
- Baseline renal insufficiency
- Glucose-6-phosphate dehydrogenase deficiency
- Taking angiotensin converting enzyme
- Angiotensin receptor blocker
- Nursing
- HIV/AIDS
- On Immunosuppressant drugs
- On Chemotherapy/Immunotherapy
- Liver dysfunction
- On the following medications: DOFETILIDE, METHENAMINE \& LEVOMETHADYL; WARFARIN \& Methotrexate; GEMIFLOXACIN, DIGOXIN, PYRIMETHAMINE, CLASS IA ANTIARRHYTHMIC AGENTS (Quinidine, procainamide, disopyramide), TRICYCLIC ANTIDEPRESSANTS (amitriptyline, desipramine, doxepin, Imipramine, nortriptyline, amoxapine, clomipramine, maprotiline, trimipramine, and protriptyline), LEUCOVORIN CALCIUM.
About this study
Official title: Effect of Antibiotics on Urinary Microbiome: Randomized Trial
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.
Read the detailed 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.
- Conditions
- Microtia, UTI, Bacteriuria, Antibiotic Resistant Infection, Antibiotics Causing Adverse Effects in Therapeutic Use
- Being tested
- Bactrim DS 800Mg-160Mg Tablet, Placebo oral tablet
- Keywords
- microbiome, antibiotics, resistance, flora
- Medical subject headings
- Congenital Microtia, Bacteriuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bactrim DS 800Mg-160Mg TabletDrug
Also called bactrim, trimethoprim sulfamethoxazole, Septra, sulfatrim
To study effect on urinary microbiome
Placebo oral tabletDrug
To study effect on urinary microbiome
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo oral tablet |
| Bactrim | Experimental | 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. Receives: Drug: Bactrim DS 800Mg-160Mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Microbiome flora number of organisms
Analysis of 16S rRNA gene amplicon data to determine number of varied organisms (genus and species).
Measured: 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).
Measured: At Baseline, Day 2, Day 5, Day 10, Day 30, and Day 180 of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study startOct 2023 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2026 (estimated)
Why it stopped: funding , recruitment issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrotiaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Planning to study the 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew J Cohen, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04230746
- Sponsor's protocol ID
- IRB00224835
- Status last verified
- Oct 2021
- First submitted
- 27 Dec 2019
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Antibiotics on Urinary Microbiome: Randomized Trial
- ClinicalTrials.gov ID
- NCT04230746
- Acronym / sponsor ID
- IRB00224835
- Conditions
- Microtia, UTI, Bacteriuria, Antibiotic Resistant Infection, Antibiotics Causing Adverse Effects in Therapeutic Use
- Keywords
- microbiome, antibiotics, resistance, flora
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: funding , recruitment issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Planning to study the 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo oral tabletParticipants 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. |
| Bactrim | Experimental | Drug: Bactrim DS 800Mg-160Mg TabletParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (17 listed)
- Diagnosed or suspected urinary tract infection in prior 6 months
- Treated with antibiotics for any reason in prior 6 months
- Allergy to sulfa
- Under 18
- Pregnant or planning to become pregnant in the next 12 months by self report (as is the clinical standard for prescribing this medication for suspected or proven UTI treatment)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bactrim DS 800Mg-160Mg TabletAlso: bactrim, trimethoprim sulfamethoxazole, Septra, sulfatrimTo study effect on urinary microbiome | Drug | Bactrim |
| Placebo oral tabletTo study effect on urinary microbiome | Drug | Placebo |
Primary outcome
Change in Microbiome flora number of organisms
Time frame: At Baseline, Day 2, Day 5, Day 10, Day 30, and Day 180 of study
Analysis of 16S rRNA gene amplicon data to determine number of varied organisms (genus and species).
Change in Microbiome flora percentage distribution of organisms
Time frame: At Baseline, Day 2, Day 5, Day 10, Day 30, and Day 180 of study
Analysis of 16S rRNA gene amplicon data to determine the percent distribution of organisms (microbiologic genus and species).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew J Cohen, MD principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Bactrim DS 800Mg-160Mg Tablet in people with Microtia and UTI, run by Johns Hopkins University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Microbiome flora number of organisms (time frame: At Baseline, Day 2, Day 5, Day 10, Day 30, and Day 180 of study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2021.