Меню
Набор скоро начнётся NCT07519681

Effects of Berberine on the Human Gut Microbiome

Без фазы С лечением Colorectal Adenomas Colorectal Cancers

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: Berberine Hydrochloride.
Кому может быть актуально
Состояния в реестре: Colorectal Adenomas, Colorectal Cancers. Базовые параметры: 18 лет — 75 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Effects of Berberine on the Human Gut Microbiome: An Exploratory Study in Healthy Volunteers and Patients With Colorectal Adenomas

Обзор

Berberine hydrochloride is a conventional component in Chinese medicine. In recent years, anticancer activity of berberine hydrochloride have been explored. The aim of this study is to investigate the effect of berberine hydrochloride on the human gut microbiome.

Вмешательства

  • Препарат Berberine Hydrochloride
    Oral Administration of Berberine Hydrochloride

Первичные конечные точки

  • Relative abundance of Akkermansia in fecal samples as measured by quantitative PCR (qPCR) [Срок оценки: 2 weeks]
Вторичные конечные точки (5)
  • Relative abundance and diversity of gut microbiota in fecal samples as assessed by 16S rRNA gene sequencing [Срок оценки: 2 weeks]
  • Plasma concentration of indole-3-pyruvic acid (IPyA) as measured before and after berberine hydrochloride administration [Срок оценки: 2 weeks]
  • Fecal concentration of indole-3-pyruvic acid (IPyA) as measured before and after berberine hydrochloride administration [Срок оценки: 2 weeks]
  • Number of participants with abnormal liver and renal function laboratory values [Срок оценки: 2 weeks]
  • Proportion of VEGFA-positive cells in adenoma tissue as assessed by immunohistochemistry [Срок оценки: Baseline and at follow-up colonoscopy (approximately 6 months [±2 months] after treatment)]

Критерии участия

Критерии включения

Outpatients undergoing colonoscopy at Renji Hospital who meet the following criteria:

  • Aged 18-75 years;
  • Had at least one but no more than six histologically confirmed colorectal adenomas (including tubular, tubulovillous, and villous adenomas) removed within 6 months prior to enrollment;
  • Provide informed consent for this study and are able to comply with the requirements for collecting qualified stool specimens, peripheral blood specimens, and providing relevant lifestyle and medical history information.

Healthy subjects who meet the following criteria:

  • Aged 18-75 years;
  • Have undergone colonoscopy within 6 months prior to enrollment with no histologically confirmed colorectal adenomas (including tubular, tubulovillous, and villous adenomas);
  • Provide informed consent for this study and are able to comply with the requirements for collecting qualified stool specimens, peripheral blood specimens, and providing relevant lifestyle and medical history information.

Критерии исключения

The following outpatients undergoing colonoscopy at Renji Hospital:

  • Incomplete resection of adenoma during colonoscopy;
  • Individuals at high risk for hereditary colorectal cancer;
  • Regular use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), COX-2 inhibitors, calcium, or vitamin D (defined as daily intake of ≥100 mg aspirin and ≥1200 mg calcium for at least 3 months);
  • History of subtotal gastrectomy, total gastrectomy, or partial enterectomy;
  • History of severe cardiac, hepatic, renal disease, or cancer;
  • Severe constipation or psychiatric disorders;
  • Pregnant, breastfeeding, or planning to become pregnant;
  • Undergone colonoscopy with inadequate bowel preparation (rated as "poor" or "insufficient" according to the Aronchik scale) or short observation time (withdrawal time <6 minutes).
  • Use of antibiotics, probiotics, or prebiotics within 1 month prior to enrollment.

The following healthy subjects:

  • Individuals at high risk for hereditary colorectal cancer;
  • Regular use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), COX-2 inhibitors, calcium, or vitamin D (defined as daily intake of ≥100 mg aspirin and ≥1200 mg calcium for at least 3 months);
  • History of subtotal gastrectomy, total gastrectomy, or partial enterectomy;
  • History of severe cardiac, hepatic, renal disease, or cancer;
  • Severe constipation or psychiatric disorders;
  • Pregnant, breastfeeding, or planning to become pregnant;
  • Undergone colonoscopy with inadequate bowel preparation (rated as "poor" or "insufficient" according to the Aronchik scale) or short observation time (withdrawal time <6 minutes).
  • Use of antibiotics, probiotics, or prebiotics within 1 month prior to enrollment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07519681 · KY2025-112-B

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗