NCT07832409Completed
Cranberry Proanthocyanidins and Lactobacilli for Recurrent UTI Prevention in Type 2 Diabetes
High-Potency Cranberry Proanthocyanidins and Lactobacilli for Recurrent Urinary Tract Infection Prevention in Women With Type 2 Diabetes: A Prospective Single-Arm Feasibility Study
Source: ClinicalTrials.gov · Last updated 22 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 16 Sept 2026
- Start date
- 10 Sept 2025
- Primary completion date
- 18 Mar 2026
- Lead sponsor
- National Institute of Endocrinology, Georgia
- Diseases
- Type 2 diabetes
- NCT number
- NCT07832409
What you commit to
- Study type: Interventional
- Participants enrolled: 100
- From 10 Sept 2025 to the primary completion date, 18 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Active, symptomatic urinary tract infection at the time of screening.
- Severe hepatic impairment or active malignancy.
- Known allergy or hypersensitivity to cranberry extracts, proanthocyanidins, or any excipient in the study formulation.
Lab values
- Severe renal impairment (eGFR \< 30 mL/min/1.73 m2) or end-stage renal disease.
Other
- Known anatomical or functional urinary tract abnormalities (e.g., neurogenic bladder, urinary tract obstruction, indwelling catheter).
- Pregnancy, lactation, or women planning pregnancy during the study duration.
Who the study is looking for
- 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.
Age in the registry: 40 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institute of Endocrinology Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.