Overview

Effect of Antibiotics on Urinary Microbiome

Status:
Withdrawn
Trial end date:
2026-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Johns Hopkins University
Treatments:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Sulfamethoxazole
Trimethoprim
Trimethoprim, Sulfamethoxazole Drug Combination
Criteria
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.