Clinical trial NCT05065008: The Roles of Gut Microbiome in UTI Susceptible Women
Official title: Investigate the Roles of Gut Microbiome in the Differential Responses of UTI Susceptible Women to Cranberry Juice Intake
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Cranberry
UTI
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: United States Department of Agriculture (USDA)
First posted: 2021-10-01
Enrollment: 160
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in the unrinary anti-adhesion activity of UTI susceptible women
timeFrame: Baseline up to 21 days of each intervention
Secondary outcomes:
measure: Determine the compositional differences of gut microbiome in responders and non-responders after the cranberry juice intake
timeFrame: Baseline up to 21 days of each intervention
measure: Identify anti-adhesion urinary biomarkers in responders versus non-responders after the cranberry juice intake
timeFrame: Baseline upt to 21 days of each intervention
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Liwei Gu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Gary P Wang, PhD
role: STUDY_DIRECTOR
References: