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Идёт набор NCT04846803

Bacterial Interference for Preventing Recurrent Urinary Tract Infection - New Ways of Treatment

Без фазы С лечением Recurrent Urinary Tract Infections

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: ABU bladder lavage, Saline bladder lavage.
Кому может быть актуально
Состояния в реестре: Recurrent Urinary Tract Infections. Базовые параметры: 18 лет — 90 лет · Все.
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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Обзор

Urinary tract infection (UTI) is one of the most common bacterial infections worldwide. It affects 150 million people annually. Treatment of patients with UTI entails a high consumption of antibiotics and large social and health costs. With this protocol, we want to elucidate alternative treatment methods for especially recurrent urinary tract infection. Bacteria have internal competitiveness (bacterial interference) and it is known that the non-pathogenic E.coli can outcompete the pathogenic E.coli in laboratory studies. We intend to strengthen the clinical evidence that it can be used as patient treatment through a clinical, placebo-controlled, double-blind trial at Odense University Hospital.

Подробное описание

Urinary tract infection (UTI) is one of the most common bacterial infections worldwide. It affects 150 million people annually. Treatment of patients with UTI entails a high consumption of antibiotics and large social and health costs. With this protocol, we want to elucidate alternative treatment methods for especially recurrent urinary tract infection. Bacteria have internal competitiveness (bacterial interference) and it is known that the non-pathogenic E.coli can outcompete the pathogenic E.coli in laboratory studies.

We intend to strengthen the clinical evidence that it can be used as patient treatment through a clinical, placebo-controlled, double-blind trial at Odense University Hospital.

Claim to be investigated:

* The non-pathogenic bacterial strain (ABU) E.coli can overcome the most common pathogenic E.coli (UPEC) in humans. * ABU can be used for preventive treatment in patients with recurrent urinary tract infections.

Clinical effect of preventive treatment (prophylactic treatment) with the non-pathogenic bacterial strain (ABU) in a selected group of patients with recurrent cystitis: A clinical, placebo-controlled, triple-blinded study.

Вмешательства

  • Биопрепарат ABU bladder lavage
    Clinical effect of preventive treatment (prophylactic treatment) - bladder lavage with the non-pathogenic bacterial strain (ABU)
  • Биопрепарат Saline bladder lavage
    Clinical effect of preventive treatment (prophylactic treatment) - bladder lavage with saline

Первичные конечные точки

  • The number of UTI events in the follow-up period [Срок оценки: 1½ year]
Вторичные конечные точки (12)
  • Time to first UTI after the intervention [Срок оценки: 1½ year]
  • Quality of life by standard Questionnaires_ICIQ-OABqol 08/04 [Срок оценки: 1½ year]
  • O´Leary-Sant Voiding and Pain symptom score [Срок оценки: 1½ year]
  • EQ-5D-5L [Срок оценки: 1½ year]
  • CRF [Срок оценки: 1½ year]
  • Hospitalization [Срок оценки: 1½ year]
  • Complications (bleeding, pain) [Срок оценки: 1½ year]
  • Microbiological diagnostics: Etiology, resistance [Срок оценки: 1½ year]
  • Creatinin [Срок оценки: 1½ year]
  • Leukocytes and neutrofilocytes [Срок оценки: 1½ year]
  • Natrium and kalium [Срок оценки: 1½ year]
  • CRP [Срок оценки: 1½ year]

Критерии участия

Критерии включения

  • Diagnosed with recurrent cystitis including 2 times of rUTI within the last 6 months or 3 times in the last 12 months, where at least 2 cultures show the same bacteria.
  • Normal investigation for lower urinary tract diseases (LUTD) including voiding diary, symptom scores, flexible cystoscopy, voiding diagram and test for residual urine.
  • Failed previously treatments.
  • Patients with native bladder with both spontaneous voiding, the need for clean intermittent catheter (CIC) or indwelling catheter.
  • Patients with neurogenic and non-neurogenic bladder dysfunction.
  • Patients with urostomy, kidney transplantation or another complicated genesis.
  • Written consent.

Критерии исключения

  • Malignancy in the urinary tract, kidney-, ureteral- or bladder stones, age < 18 years, pregnancy, breastfeeding. Patients in ongoing orally antibiotic treatment. Not able to speak or understand Danish.

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
Профилактика

Центры проведения

Дания · 2 центра
  • Aarhus University Hospital — Aarhus N
  • Odense University Hospital — Odense C

Идентификаторы

NCT: NCT04846803 · BIrUTI

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗