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

  • End date
    Jul 10, 2023
  • participants needed
  • sponsor
Updated on 1 March 2022


Correlation of Microbiome to Chronic Urinary Tract Infections (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 UTI types.

Condition Chronic UTI, Chronic Urinary Tract Infection
Treatment No intervention
Clinical Study IdentifierNCT04100980
Last Modified on1 March 2022


Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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Step 1 Connect with a study center
What happens next?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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