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

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.

• No Intervention (Other): There is no intervention for this study

Primary outcomes

• 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 outcomes

• Validation of Sequencing Methods [1 year]: To validate the methods used to sequence samples

Sex: All, ages: 18 Years to any

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.

• Sabine Hazan, MD, Principal investigator, ProgenaBiome