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
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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
Women with type 2 diabetes mellitus (T2DM) are disproportionately affected by recurrent urinary tract infections due to glucosuria, impaired innate immune defenses, and urogenital dysbiosis, which is often compounded by the use of sodium-glucose cotransporter-2 (SGLT2) inhibitors.
This prospective, open-label, single-arm feasibility study was conducted at the National Institute of Endocrinology in Tbilisi, Georgia. Eligible participants were women aged 40 to 75 years with established T2DM (HbA1c 6.5%-10.0%) and a confirmed history of recurrent UTIs (defined as >=2 episodes in the prior 12 months or >=1 in the prior 6 months) without active infection at enrollment.
The study protocol comprised:
- Screening window: up to 14 days to confirm eligibility and baseline stability.
- Active intervention phase: 60 consecutive days of oral supplementation with a commercial capsule containing 72 mg of standardized cranberry PACs and 2x10^9 CFU of a multi-strain Lactobacillus formulation (L. rhamnosus, L. acidophilus, L. casei) taken twice daily with meals (total 144 mg PACs daily).
- Observation phase: 120 days of prospective follow-up without study supplementation.
Standard glucose-lowering therapies (including metformin and SGLT2 inhibitors) were maintained unchanged throughout the 180-day study. The study was designed to generate operational, safety, and preliminary signal data to inform the sample size calculation and methodological design of a future randomized, double-blind, placebo-controlled clinical trial.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Tbilisi, Gruzie, 0159
- National Institute of Endocrinology
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Active Supplementation Arm
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. |
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.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Study Completion and Retention Rate
Časové okno: Day 180
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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
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Incidence of Symptomatic Recurrent Urinary Tract Infections (rUTIs)
Časové okno: Day 1 to Day 180
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Number of microbiologically confirmed symptomatic UTI episodes (presence of acute urinary symptoms accompanied by significant bacteriuria >= 10^3 to 10^5 CFU/mL) recorded per participant during the 180-day evaluation period. |
Day 1 to Day 180
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Frequency of Antibiotic Courses Prescribed for UTI
Časové okno: Day 1 to Day 180
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Total number of systemic antibacterial treatment courses initiated for acute symptomatic urinary tract infections during the 180-day study period. |
Day 1 to Day 180
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Incidence of Treatment-Emergent Adverse Events
Časové okno: Day 1 to Day 60 (active intervention period)
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Incidence, severity, and causality assessment of adverse events reported during the active supplement period, with particular focus on gastrointestinal tolerability (e.g., dyspepsia, nausea, abdominal discomfort). |
Day 1 to Day 60 (active intervention period)
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Shota Janjgava, MD, PhD, National Institute of Endocrinology, Georgia
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Urogenitální onemocnění
- Onemocnění endokrinního systému
- Mužská urogenitální onemocnění
- Urologická onemocnění
- Ženské urogenitální onemocnění
- Ženské urogenitální onemocnění a těhotenské komplikace
- Metabolické choroby
- Infekce
- Poruchy metabolismu glukózy
- Diabetes Mellitus
- Nutriční a metabolické nemoci
- Diabetes mellitus, typ 2
- Infekce močového ústrojí
Další identifikační čísla studie
- NIE-T2D-UTI-01
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
De-identified individual participant data that underlie the results reported in this article will be made available upon reasonable request to qualified academic researchers for scientific verification.
Časový rámec sdílení IPD
Data will be available beginning 6 months and ending 36 months following publication of the study results.
Kritéria přístupu pro sdílení IPD
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.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- ICF
Informace o lécích a zařízeních, studijní dokumenty
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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