WithdrawnEarly Phase 1

Effect of Antibiotics on Urinary Microbiome

Stopped: funding , recruitment issues

0Started 2023-10

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion Criteria: * 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 * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Microbiome flora number of organisms

Timeframe: At Baseline, Day 2, Day 5, Day 10, Day 30, and Day 180 of study

Change in Microbiome flora percentage distribution of organisms

Timeframe: At Baseline, Day 2, Day 5, Day 10, Day 30, and Day 180 of study

Trial details

NCT IDNCT04230746

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02

View on ClinicalTrials.gov More Microtia trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.