A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Chronic Urinary Tract Infections (UTI)

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04100980

Enrollment

Registered

2019-09-24

Start date

2020-03-02

Completion date

2030-07-31

Last updated

2025-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Urinary Tract Infection, Chronic UTI

Brief summary

Correlation of Microbiome to Chronic Urinary Tract Infections (UTI) via Relative Abundance Found in Microbiome Sequencing

Detailed description

Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized among specific Chronic UTI types.

Interventions

OTHERNo Intervention

There is no intervention for this study

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Signed informed consent by patient 2. Male or female patients age 18 and older. 3. Diagnosis of chronic UTIs by a physician based upon urinalysis and/or urine culture.

Exclusion criteria

1. Refusal by patient to sign informed consent form 2. Treatment with antibiotics within 2 weeks prior to screening 3. Treatment with probiotics within 6 weeks prior to screening 4. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. 5. Postoperative stoma, ostomy, or ileoanal pouch 6. Participation in any experimental drug protocol within the past 12 weeks 7. Treatment with total parenteral nutrition 8. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial 9. Inability of patient to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study.

Design outcomes

Primary

Measure	Time frame	Description
Correlation of Microbiome to chronic Urinary Tract Infection (UTI) via Relative Abundance Found in Microbiome Sequencing	1 year	Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized among specific chronic urinary tract infection (UTI) types.

Secondary

Measure	Time frame	Description
Validation of Sequencing Methods	1 year	To validate the methods used to sequence samples

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026