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COMPLETED
NCT07832409
NA

Cranberry Proanthocyanidins and Lactobacilli for Recurrent UTI Prevention in Type 2 Diabetes

Sponsor: National Institute of Endocrinology, Georgia

View on ClinicalTrials.gov

Summary

The purpose of this prospective, single-arm feasibility study was to evaluate the operational feasibility, tolerability, safety, and exploratory clinical outcomes of an oral supplement combining standardized cranberry proanthocyanidins (PACs) and a multi-strain Lactobacillus formulation in women with type 2 diabetes mellitus and a documented history of recurrent urinary tract infections (rUTIs). Participants received a 60-day active intervention consisting of a combined capsule taken twice daily, followed by a 120-day observation period without study intervention, for a total follow-up duration of 180 days. Primary feasibility outcomes included screening and enrollment metrics, retention rate at day 180, and tolerability/adverse event rates. Exploratory endpoints included the incidence of microbiologically confirmed symptomatic UTIs and changes in antibiotic prescription rates compared with pre-enrollment history.

Official title: High-Potency Cranberry Proanthocyanidins and Lactobacilli for Recurrent Urinary Tract Infection Prevention in Women With Type 2 Diabetes: A Prospective Single-Arm Feasibility Study

Key Details

Gender

FEMALE

Age Range

40 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-09-10

Completion Date

2026-03-18

Last Updated

2026-09-22

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Cranberry Proanthocyanidins and Lactobacilli

Oral capsule containing 72 mg of standardized cranberry proanthocyanidins (PACs) and 2x10\^9 CFU multi-strain Lactobacillus (L. rhamnosus, L. acidophilus, L. casei), administered twice daily with meals for 60 consecutive days.

Locations (1)

National Institute of Endocrinology

Tbilisi, Georgia