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 range18 Years

SexALL

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.

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 range18 Years

SexALL

See this in plain English?

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