- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05065008
The Roles of Gut Microbiome in UTI Susceptible Women
May 8, 2023 updated by: University of Florida
Investigate the Roles of Gut Microbiome in the Differential Responses of UTI Susceptible Women to Cranberry Juice Intake
Clinical trials on cranberry juice and UTI prevention yielded both positive and negative results for unknown reason.
Gut microbiome in women affect the absorption and metabolism of cranberry bioactives.
The variation of gut microbiome is a probable mechanism for metabolic polymorphisms and disparity in UTI prevention in women.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The American cranberries, especially cranberry juice, have used for centuries as a folk medicine to prevent urinary tract infections (UTI), which affect 50% of women in their lifetime.
Over 40 clinical trials have been conducted in the last 20 years to verify the UTI preventatively activity of cranberry juices, but the results were contradictory.
About 90% of UTI are initiated by the adhesion of uropathogenic E. coli (UPEC) on urinary tract epithelia.
It was reported that human urine after consumption of cranberry juice inhibited the adhesion of UPEC.
The A-type proanthocyanidins and xyloglucans are the presumed bioactives in cranberries, however, this is unlikely because these two classes of compounds have extremely low bioavailability in human body.
Preliminary research suggested that women can be either "resistant" or "susceptible" to UTI depending on the inherent anti-adhesion activity in their urine against UPEC before consuming cranberry juice.
Not all but a fraction of "UTI susceptible" women had increased urinary anti-adhesion activity after consuming cranberry juices.
These women are classified as "responders" and others are "non-responders".
The variation of gut microbiome is a probable mechanism for metabolic polymorphisms and disparity in UTI prevention.
The objective of this trials is to identify gut microbes and anti-adhesive urinary biomarkers which significantly contribute to the anti-adhesion of UPEC.
Study Type
Interventional
Enrollment (Anticipated)
160
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Liwei Gu, PhD
- Phone Number: 3522943730
- Email: lgu@ufl.edu
Study Contact Backup
- Name: Shuhan Li, Master
- Phone Number: 3523280624
- Email: lishuhan@ufl.edu
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32611
- Recruiting
- University of Florida
-
Contact:
- Shuhan Li, Master
- Phone Number: 352-328-0624
- Email: lishuhan@ufl.edu
-
-
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
21 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Healthy women participants;
- BMI 18.5-29.9 kg/m2;
- At least 110 pounds in weight
Exclusion Criteria:
- BMI≥ 30 kg/m2;
- Pregnancy and breast-feeding;
- Smoking, frequent alcohol use;
- History of any clinically important disorder that may interfere with interpretation of the results;
- Intake of medication that might influence the outcome of the 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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cranberry juice consumption
Participants deemed as responders and non-responders will be given 20-30 oz (590-885 mL) of cranberry juice daily for 3 weeks.
|
The responders and non-responders will drink 20-30 oz of (590-885 mL) 27% cranberry juice daily for 3 weeks.
|
Experimental: Apple juice consumption
Participants deemed as responders and non-responders will be given 20-30 oz (590-885 mL) apple juice with matching sugar and calories daily for 3 weeks.
|
The participants will drink apple juice with matching sugar content and calories for 3 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the unrinary anti-adhesion activity of UTI susceptible women
Time Frame: Baseline up to 21 days of each intervention
|
Compare the statistical differences between the changes from baseline in the an-adhesion activity against uropathogenic E. coli in UTI-susceptible women after consuming the cranberry juice for 3 weeks versus after consuming the placebo juice for 3 weeks.
Anti-adhesion activity in urine will be measured using a fluorescence-based microplate method.
The anti-adhesion activities of urines will be expressed by its equivalence to myricetin level.
The unit for urine anti-adhesion activities is µg myricetin/mg creatinine.
|
Baseline up to 21 days of each intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine the compositional differences of gut microbiome in responders and non-responders after the cranberry juice intake
Time Frame: Baseline up to 21 days of each intervention
|
Compare the differences in the gut microbiomes between responders and non-responders after consuming the cranberry juice for 3 weeks versus after consuming the placebo juice for 3 weeks.
Human feces collected from responders and non-responders will be analyzed for microbiota composition.
Relative abundance of gut microbiome at phylum level, family level, genus level, and Firmicutes over Bacteroidetes ratio will be evaluated.
Genomic microbial DNA will be extracted from fecal samples using DNA isolation kits.
The 16S ribosomal RNA gene (V1-3 region) of each sample will be amplified and sequenced using a barcoding system on a MiSeq sequencer.
Sequence data will be analyzed using the latest version of QIIME.
|
Baseline up to 21 days of each intervention
|
Identify anti-adhesion urinary biomarkers in responders versus non-responders after the cranberry juice intake
Time Frame: Baseline upt to 21 days of each intervention
|
Determine the impacts of cranberry juice intake on the urinary metabolome and identify anti-adhesion urinary biomarkers in responders and non-responders after consuming the cranberry juice for 3 weeks versus after consuming the placebo juice for 3 weeks.
Metabolites in urine will be detected using UHPLC-HRMS and annotated using combination of m/z and retention time.
Metabolites that significantly contribute to the anti-adhesion activity of urine revealed by PLS regression analysis are the potential anti-adhesion biomarkers.
A list of potential biomarkers will be generated.
Structures of these biomarkers will be tentatively determined through spectral analysis and database searching.
Structure of tentatively identified biomarkers will be confirmed by comparing with authentic standards.
|
Baseline upt to 21 days of each intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Gary P Wang, PhD, University of Florida
- Principal Investigator: Liwei Gu, PhD, University of Florida
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)
October 18, 2021
Primary Completion (Anticipated)
August 1, 2025
Study Completion (Anticipated)
August 1, 2025
Study Registration Dates
First Submitted
September 29, 2021
First Submitted That Met QC Criteria
September 29, 2021
First Posted (Actual)
October 1, 2021
Study Record Updates
Last Update Posted (Actual)
May 9, 2023
Last Update Submitted That Met QC Criteria
May 8, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 2021-09003
- IRB202102165 (Other Identifier: UF IRB-01)
- PRO00039868 (Other Identifier: UF UFIRST)
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.
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