Набор по приглашению NCT06855355

CBM588 Reduces Colorectal Polyp Recurrence

Без фазы С лечением Colorectal Polyp

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: Clostridium butyricum MIYAIRI 588.
Кому может быть актуально: Состояния в реестре: Colorectal Polyp. Базовые параметры: от 18 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: Тайвань
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

Clostridium Butyricum MIYAIRI 588 Reduces Colorectal Adenomatous Polyp Recurrence: A Randomized Crossover Trial

Обзор

The goal of this randomized crossover clinical trial is to evaluate the efficacy of Clostridium butyricum MIYAIRI 588 (CBM588) in reducing colorectal adenomatous polyp recurrence in adult patients with a history of colorectal polyps. The main questions it aims to answer are: * Does CBM588 reduce the recurrence of colorectal adenomatous polyps? * Does CBM588 lead to a sustained decrease in polyp burden over time? Researchers will compare a group receiving CBM588 in the first year to a group receiving CBM588 in the second year (after a washout period) to determine whether CBM588 effectively lowers polyp recurrence rates and adenoma prevalence.

Подробное описание

This randomized crossover clinical trial evaluates the effect of Clostridium butyricum MIYAIRI 588 (CBM588), a butyrate-producing probiotic, on colorectal adenomatous polyp recurrence. Participants who had undergone complete polypectomy were randomly assigned into two groups:

* Group A: Received CBM588 for one year, followed by a washout period and no treatment in the second year. * Group B: Did not receive CBM588 in the first year but received it in the second year after a washout period.

Annual colonoscopy assessments were conducted to evaluate polyp count, type, and location. The primary outcome measure is adenoma recurrence. This study was conducted at a tertiary medical center and received Institutional Review Board (IRB) approval (KMUHIRB-F(I)-20170010). All participants provided informed consent.

Вмешательства

Пищевая добавка Clostridium butyricum MIYAIRI 588
A butyrate-producing probiotic, has demonstrated potential anti-inflammatory and anti-tumorigenic effects.

Первичные конечные точки

Colorectal polyp recurrence rate (%) [Срок оценки: 1 year and 2.25 years after baseline colonoscopy]

Вторичные конечные точки (3)

Adenomatous polyp recurrence rate (%) [Срок оценки: 1 year and 2.25 years after baseline colonoscopy]
Mean number of recurrent polyps [Срок оценки: 1 year and 2.25 years after baseline colonoscopy]
Polyp location distribution [Срок оценки: 1 year and 2.25 years after baseline colonoscopy]

Критерии участия

Критерии включения

Adults with a history of colorectal adenomas that had been completely removed by endoscopic resection within the past three years, and who presented with recurrent colorectal polyps detected during surveillance colonoscopy
Willingness to undergo follow-up colonoscopies at study intervals
No antibiotic or probiotic use for at least three months before study entry
Written informed consent obtained