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

NCT04100980 | Withdrawn DMC

• 1 other identifier: PRG-014
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic UTI; Chronic Urinary Tract Infection

Outcome Measures

Primary Outcomes (1)

• Correlation of Microbiome to chronic Urinary Tract Infection (UTI) via Relative Abundance Found in Microbiome Sequencing

  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.

  1 year

Secondary Outcomes (1)

• Validation of Sequencing Methods

  1 year

Study Arms (1)

Chronic UTI

Patients who have been diagnosed with chronic urinary tract infections (UTI).

Other: No Intervention

Interventions

No Intervention OTHER

There is no intervention for this study

Chronic UTI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients 18 years of age or older who have been diagnosed with chronic urinary tract infections (UTI)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• ProgenaBiome: lead

Study Sites (1)

ProgenaBiome

Ventura, California, 93003, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool Samples

Study Officials

• Sabine Hazan, MD

  ProgenaBiome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: September 24, 2019
• Study Start: March 2, 2020
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: June 5, 2025

Record last verified: 2025-06

Locations

US (1)