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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Tbilisi, 그루지야, 0159
- National Institute of Endocrinology
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Study Completion and Retention Rate
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Incidence of Symptomatic Recurrent Urinary Tract Infections (rUTIs)
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Shota Janjgava, MD, PhD, National Institute of Endocrinology, Georgia
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- NIE-T2D-UTI-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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.
IPD 공유 기간
Data will be available beginning 6 months and ending 36 months following publication of the study results.
IPD 공유 액세스 기준
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.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- ICF
약물 및 장치 정보, 연구 문서
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