The Roles of Gut Microbiome in UTI Susceptible Women

NCT ID: NCT05065008

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-18
• Study Completion Date: 2026-08-31

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.

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cranberry juice

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Apple juice

Intervention Type: OTHER

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

Interventions

Cranberry juice

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

Intervention Type: OTHER

Apple juice

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

United States Department of Agriculture (USDA)

FED

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Liwei Gu, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Gary P Wang, PhD

Role: STUDY_DIRECTOR

University of Florida

Locations

University of Florida

Gainesville, Florida, United States

Countries

United States

Other Identifiers

IRB202102165

Identifier Type: OTHER

Identifier Source: secondary_id

PRO00039868

Identifier Type: OTHER

Identifier Source: secondary_id

2021-09003

Identifier Type: -

Identifier Source: org_study_id