- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04100980
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Chronic Urinary Tract Infections (UTI)
September 2, 2021 updated by: ProgenaBiome
Correlation of Microbiome to Chronic Urinary Tract Infections (UTI) via Relative Abundance Found in Microbiome Sequencing
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Anticipated)
25
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Ventura, California, United States, 93003
- Recruiting
- ProgenaBiome
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients 18 years of age or older who have been diagnosed with chronic urinary tract infections (UTI)
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Chronic UTI
Patients who have been diagnosed with chronic urinary tract infections (UTI).
|
There is no intervention for this study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Validation of Sequencing Methods
Time Frame: 1 year
|
To validate the methods used to sequence samples
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 2, 2020
Primary Completion (ANTICIPATED)
March 1, 2023
Study Completion (ANTICIPATED)
July 1, 2023
Study Registration Dates
First Submitted
September 20, 2019
First Submitted That Met QC Criteria
September 20, 2019
First Posted (ACTUAL)
September 24, 2019
Study Record Updates
Last Update Posted (ACTUAL)
September 5, 2021
Last Update Submitted That Met QC Criteria
September 2, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRG-014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Only aggregated and deidentified data will be shared with other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Urinary Tract Infection
-
University Hospital, MontpellierRecruitingUrinary Retention | Urinary Infection | Chronic Kidney InfectionFrance
-
Impatients N.V. trading as myTomorrowsInmunotek S.L.No longer availableUrinary Tract Infections | Bladder Infection | Recurrent Urinary Tract Infection | Urinary Tract Infection Bacterial | Chronic Urinary Tract InfectionCzechia, Denmark, Serbia, France, Germany, Turkey, Belgium, Finland, Luxembourg, Netherlands, Norway, Romania, Slovakia, Slovenia, Sweden
-
University of California, San DiegoTerminatedPainful Bladder Syndrome | Recurrent Urinary Tract Infection | Chronic Interstitial CystitisUnited States
-
University of Southern DenmarkHospital of South West JutlandNot yet recruitingRecurrent Urinary Tract Infections | Antibiotic Treatment | Chronic Urinary-catheter-carrier | Biofilm Infection | Replacement of Urinary Catheter
-
ANRS, Emerging Infectious DiseasesUniversity College London Hospitals; Hospital Clinic of Barcelona; Imperial College... and other collaboratorsCompletedHIV-1-infectionFrance, United Kingdom, Switzerland
-
National Institute of Diabetes and Digestive and...CompletedHIV Infection | Chronic Kidney FailureUnited States
-
Technical University of MunichSchool of Medicine, Technical University Munich, Münchner Studienzentrum; Klinikum...RecruitingUrinary Tract Infection ChronicGermany
-
Bristol-Myers SquibbCompletedChronic Hepatitis C Virus Infection | Chronic Hepatitis B Virus InfectionUnited States
-
Gloucestershire Hospitals NHS Foundation TrustUnknownCatheter Infection | Urinary Tract Infection in Pregnancy | Urinary Tract Infection Following Delivery
-
Seattle Children's HospitalUniversity of WashingtonUnknown
Clinical Trials on No Intervention
-
Wave NeuroscienceCompletedAutistic DisorderUnited States
-
University of Alabama at BirminghamCompletedInflammatory Bowel Diseases | Colorectal Cancer | Diverticular Diseases | Social BehaviorUnited States
-
Janssen Research & Development, LLCCompletedLupus Erythematosus, Systemic | Lupus Erythematosus, Cutaneous | Lupus Erythematosus, DiscoidUnited States, Poland
-
Hospital Universitario La Paz3MVX CCB and Agaplesion Markus Krankenhaus, Frankfurt a.M., Germany.; Department...RecruitingEmbolism | Atrial Fibrillation | Arrhythmia | Stroke, Acute | Stroke Sequelae | AblationSpain
-
Southern California College of Optometry at Marshall...Ohio State University; University of Houston; Alcon Research; University of Waterloo and other collaboratorsCompletedContact Lens Complication | Contact Lens Acute Red Eye | Contact Lens Related Corneal Infiltrate (Disorder) | Contact Lens-Induced Corneal Fluorescein StainingUnited States, Canada
-
University of Dublin, Trinity CollegeCompleted
-
Hôpital Necker-Enfants MaladesUnknown
-
China Medical University HospitalUnknownIntention to Stay, Turnover Behavior
-
University of PittsburghCompletedChronic Low Back PainUnited States