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

NCT07832409 | Completed

• 1 other identifier: NIE-T2D-UTI-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes Mellitus (T2DM); Recurrent Urinary Tract Infections

Keywords

Type 2 diabetes; Recurrent urinary tract infection; Proanthocyanidins; Lactobacillus; Feasibility study; SGLT2 inhibitors

Outcome Measures

Primary Outcomes (1)

• Study Completion and Retention Rate

  Proportion of enrolled participants who successfully completed the entire 180-day protocol (comprising the 60-day active supplementation phase and the 120-day observation phase) without premature discontinuation.

  Day 180

Secondary Outcomes (3)

• Incidence of Symptomatic Recurrent Urinary Tract Infections (rUTIs)

  Day 1 to Day 180

• Frequency of Antibiotic Courses Prescribed for UTI

  Day 1 to Day 180

• Incidence of Treatment-Emergent Adverse Events

  Day 1 to Day 60 (active intervention period)

Study Arms (1)

Active Supplementation Arm

EXPERIMENTAL

Participants received oral capsules containing standardized cranberry proanthocyanidins (72 mg) and multi-strain Lactobacillus (2x10\^9 CFU) twice daily for 60 consecutive days, followed by a 120-day observation phase.

Dietary Supplement: Cranberry Proanthocyanidins and Lactobacilli

Interventions

Cranberry Proanthocyanidins and Lactobacilli DIETARY_SUPPLEMENT

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.

Also known as: Cranberry PACs + Probiotic formulation

Active Supplementation Arm

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients aged 40 to 75 years.
• Established diagnosis of type 2 diabetes mellitus for \>= 12 months.
• Baseline glycated hemoglobin (HbA1c) between 6.5% and 10.0%.
• Documented history of recurrent urinary tract infections (\>= 2 episodes in the preceding 12 months or \>= 1 episode in the preceding 6 months).
• Absence of active symptomatic UTI at enrollment, verified by screening urine analysis and culture.
• Maintained on stable glucose-lowering therapy for at least 3 months prior to enrollment.
• Willing and able to comply with the 60-day supplementation and 180-day follow-up protocol.
• Provided written informed consent.

You may not qualify if:

• Active, symptomatic urinary tract infection at the time of screening.
• Known anatomical or functional urinary tract abnormalities (e.g., neurogenic bladder, urinary tract obstruction, indwelling catheter).
• Severe renal impairment (eGFR \< 30 mL/min/1.73 m2) or end-stage renal disease.
• Severe hepatic impairment or active malignancy.
• Routine use of systemic antibiotic prophylaxis for UTI within 30 days prior to screening.
• Regular intake of cranberry-containing supplements, D-mannose, or commercial probiotic formulations within 30 days prior to enrollment.
• Known allergy or hypersensitivity to cranberry extracts, proanthocyanidins, or any excipient in the study formulation.
• Pregnancy, lactation, or women planning pregnancy during the study duration.

Sponsors & Collaborators

• National Institute of Endocrinology, Georgia: lead

Study Sites (1)

National Institute of Endocrinology

Tbilisi, 0159, Georgia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Urinary Tract Infections

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Shota Janjgava, MD, PhD

  National Institute of Endocrinology, Georgia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, open-label, single-arm feasibility design. All enrolled participants received the active dietary supplement intervention for 60 days, followed by a 120-day observation period.

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: September 22, 2026
• Study Start: September 10, 2025
• Primary Completion: March 18, 2026
• Study Completion: March 18, 2026
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available beginning 6 months and ending 36 months following publication of the study results.
• Access Criteria: De-identified individual participant data will be made available to qualified academic researchers upon reasonable request with a methodologically sound proposal. Requests should be directed to the study investigators and are subject to institutional data-sharing approval.

Locations

GE (1)