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

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ClinicalTrials.gov Identifier: NCT04100980
Recruitment Status : Not yet recruiting
First Posted : September 24, 2019
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
ProgenaBiome

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

Condition or disease Intervention/treatment
Chronic UTI Chronic Urinary Tract Infection Other: No Intervention

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Chronic Urinary Tract Infections (UTI)
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Chronic UTI
Patients who have been diagnosed with chronic urinary tract infections (UTI).
Other: No Intervention
There is no intervention for this study




Primary Outcome Measures :
  1. Correlation of Microbiome to chronic Urinary Tract Infection (UTI) via Relative Abundance Found in Microbiome Sequencing [ Time Frame: 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 Outcome Measures :
  1. Validation of Sequencing Methods [ Time Frame: 1 year ]
    To validate the methods used to sequence samples


Biospecimen Retention:   Samples With DNA
Stool Samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients 18 years of age or older who have been diagnosed with chronic urinary tract infections (UTI)
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04100980


Contacts
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Contact: Sabine Hazan, MD 8053390549 sabinehazan@aim.com
Contact: Jordan Daniels, MS 8053390549 msjordandaniels@gmail.com

Locations
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United States, California
ProgenaBiome
Ventura, California, United States, 93003
Sponsors and Collaborators
ProgenaBiome
Investigators
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Principal Investigator: Sabine Hazan, MD ProgenaBiome

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Responsible Party: ProgenaBiome
ClinicalTrials.gov Identifier: NCT04100980     History of Changes
Other Study ID Numbers: ProgenaBiome-014
First Posted: September 24, 2019    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Only aggregated and deidentified data will be shared with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases