The Roles of Gut Microbiome in UTI Susceptible Women

University of Florida

Status: Active, not recruiting

Conditions: Healthy

Treatments: Other: Cranberry juice; Other: Apple juice

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05065008

2021-09003

PRO00039868 (Other Identifier)

IRB202102165 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: Female

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Cranberry juice consumption

Experimental group

Description:

Participants deemed as responders and non-responders will be given 20-30 oz (590-885 mL) of cranberry juice daily for 3 weeks.

Treatment:

Other: Cranberry juice

Apple juice consumption

Experimental group

Description:

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.

Treatment:

Other: Apple juice