The Roles of Gut Microbiome in UTI Susceptible Women
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|ClinicalTrials.gov Identifier: NCT05065008|
Recruitment Status : Not yet recruiting
First Posted : October 1, 2021
Last Update Posted : October 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Other: Cranberry juice Other: Apple juice||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Investigate the Roles of Gut Microbiome in the Differential Responses of UTI Susceptible Women to Cranberry Juice Intake|
|Estimated Study Start Date :||December 2021|
|Estimated Primary Completion Date :||August 2025|
|Estimated Study Completion Date :||August 2025|
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.
Other: Cranberry juice
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.
Other: Apple juice
The participants will drink apple juice with matching sugar content and calories for 3 weeks
- 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.
- 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.
- 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.
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): NCT05065008
|Contact: Liwei Gu, PhDfirstname.lastname@example.org|
|Contact: Shuhan Li, Masteremail@example.com|
|United States, Florida|
|University of Florida|
|Gainesville, Florida, United States, 32611|
|Contact: Shuhan Li, Master 352-328-0624 firstname.lastname@example.org|
|Principal Investigator:||Liwei Gu, PhD||University of Florida|
|Study Director:||Gary P Wang, PhD||University of Florida|