Effect of Antibiotics on Urinary Microbiome

NCT04230746 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: IRB00224835
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Microtia; UTI; Bacteriuria; Antibiotic Resistant Infection; Antibiotics Causing Adverse Effects in Therapeutic Use

Keywords

microbiome; antibiotics; resistance; flora

Outcome Measures

Primary Outcomes (2)

• Change in Microbiome flora number of organisms

  Analysis of 16S rRNA gene amplicon data to determine number of varied organisms (genus and species).

  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).

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

Study Arms (2)

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.

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.

Drug: Bactrim DS 800Mg-160Mg Tablet

Interventions

Bactrim DS 800Mg-160Mg Tablet DRUG

To study effect on urinary microbiome

Also known as: bactrim, trimethoprim sulfamethoxazole, Septra, sulfatrim

Bactrim

Placebo oral tablet DRUG

To study effect on urinary microbiome

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

MeSH Terms

Conditions

Congenital Microtia; Bacteriuria

Interventions

Trimethoprim, Sulfamethoxazole Drug Combination

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Urinary Tract Infections; Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Trimethoprim; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Andrew J Cohen, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Drug will be blinded to all.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 27, 2019
• First Posted: January 18, 2020
• Study Start: October 1, 2023
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2026
• Last Updated: November 3, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share