The Roles of Gut Microbiome in UTI Susceptible Women

NCT05065008 | Active Not Recruiting

• 3 other identifiers: 2021-09003IRB202102165PRO00039868
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Cranberry; UTI

Outcome Measures

Primary Outcomes (1)

• Change in the unrinary anti-adhesion activity of UTI susceptible women

  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 Outcomes (2)

• Determine the compositional differences of gut microbiome in responders and non-responders after the cranberry juice intake

  Baseline up to 21 days of each intervention

• Identify anti-adhesion urinary biomarkers in responders versus non-responders after the cranberry juice intake

  Baseline upt to 21 days of each intervention

Study Arms (2)

Cranberry juice consumption

EXPERIMENTAL

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

Apple juice consumption

EXPERIMENTAL

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

Interventions

Cranberry juice OTHER

The responders and non-responders will drink 20-30 oz of (590-885 mL) 27% cranberry juice daily for 3 weeks.

Cranberry juice consumption

Apple juice OTHER

The participants will drink apple juice with matching sugar content and calories for 3 weeks

Apple juice consumption

Eligibility Criteria

• Age: 21 Years - 65 Years
• Gender Eligibility Details: Women is a group which is susceptible to urinary tract infections (UTIs) based on previous papers. This study will determine American cranberries to prevent UTIs in susceptible women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy women participants;
• BMI 18.5-29.9 kg/m2;
• At least 110 pounds in weight

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• United States Department of Agriculture (USDA): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

Study Officials

• Liwei Gu, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

• Gary P Wang, PhD

  University of Florida

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 1, 2021
• Study Start: October 18, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-09

Locations

US (1)