The Effect of ASTARTE™ on Recurrent Urinary Tract Infection
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: ASTARTE™ oral capsules, Placebo oral capsules.
- Кому может быть актуально
- Состояния в реестре: Recurrent Urinary Tract Infection. Базовые параметры: 18 лет — 40 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Дания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The Effect of ASTARTE™; Lactobacillus Crispatus, Lactobacillus Rhamnosus, Lactobacillus Jenesii and Lactobacillus Gasseri on the Reduction of Risk Factors for Recurrent Urinary Tract Infection in Women
Обзор
Investigate the effect of dietary supplements/probiotic ASTARTE™ ( L. crispatus, L. rhamnosus, L. jensenii, L. gasseri) on the microbiome composition in the intestine and vagina and thereby a reduction of risk factors for the development of rUTI during 6 months of intervention in women aged 18-40 years. This is measured by the incidence of symptomatic UTI.
Подробное описание
Urinary tract infection (UTI) is one of the most common infections, contributing to increased antibiotic consumption and high costs. Women are often developing UTI due to the anatomically short distance from the rectum opening to the urethra. There is a risk of serious complications associated with pregnancy, where there is an increased risk of developing pelvic inflammatory disease and premature birth. This will in some cases lead to increased risk of maternal and neonatal morbidity and mortality; especially in infection with Streptococcus agalactiae. Recurrent UTI (rUTI) with urease producing microorganisms such as Proteus and Klebsiella will cause an increased risk of developing stones in the urinary tract.
Scientific studies suggest that probiotics can be effective dietary supplements reducing the risk factors for the development of infections in the intestine and vagina. Probiotics are non-pathogenic microorganisms capable of affecting gastrointestinal microbiota with a change in microbiota composition, thus increasing the production of beneficial substances when ingested in appropriate quantities. The consumption of probiotics is not considered to be associated with adverse reactions to humans because they are usually found naturally in e.g. gastrointestinal and vaginal microbiota.
A prospective study over 2-years which is conducted as a randomized placebo-controlled double-blind study. In this study the investigators will investigate the effect of probiotics ASTARTE™ ( Lactobacillus crispatus, Lactobacillus rhamnosus, Lactobacillus jensenii, Lactobacillus gasseri) on the composition of bacteria in urine, faces and vagina, and a possible reduction of risk factors for development of rUTI in women (18 to 40 years). The investigators will map the microbiota in the faeces and vagina and examine if there are a relationship between colonization of the urinary tract with pathogens and the composition of the intestinal and vaginal microbiota.
Вмешательства
- Пищевая добавка ASTARTE™ oral capsules
1 Capsule daily for 6 months - Пищевая добавка Placebo oral capsules
1 Capsule daily for 6 months
Первичные конечные точки
- Reduction of UTI cases [Срок оценки: 6 months]
Вторичные конечные точки (4)
- Number of UTI after intervention [Срок оценки: 12 months]
- UTI symptoms [Срок оценки: 12 months]
- Change of vaginal microbiome [Срок оценки: 6 months]
- Change of gut microbiome [Срок оценки: 6 months]
Критерии участия
Критерии включения
- Women 18-40 years of age
- Recurrent UTI (2 times UTI within 6 months or > 3 times UTI infection within one year).
- The subjects should be informed about the trial protocol.
- The subject must be able to follow the protocol, have provided voluntary consent and have signed the declaration of consent.
Критерии исключения
- Pregnancy or planning pregnancy
- Breastfeeding
- Participation in another trial with probiotic the last 30 days.
- Hypersensitivity to any ingredient in the study product
- Patients primarily admitted for a disorder other than UTI
- Antibiotic treatment for any other condition than UTI at time of recruitment the last 30 days
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Четверное слепое
- Основная цель
- Организация здравоохранения
Центры проведения
Дания · 1 центр
- Gastrounit, Copenhagen University Hospital Hvidovre — Hvidovre
Публикации
- Ghathian KSA, Halkjaer SI, Krogfelt KA, Frimodt-Moller N, Hansen KH, Frederiksen AKS, Holm A, Petersen AM. The effect of the probiotic supplement-ASTARTE-on the reduction of recurrent urinary tract infection in women aged 18-40 years: protocol for a randomized, double-blind, placebo-controlled study. Trials. 2026 Apr 7;27(1):383. doi: 10.1186/s13063-026-09679-3. PMID 41943076
Идентификаторы
NCT: NCT05553652 · H-22014666