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Набор скоро начнётся NCT06779214

Effect of Food-derived Active Components on Digestive Tract Health in Adults with Irritable Bowel Syndrome

Без фазы С лечением Irritable Bowel Syndrome - Diarrhoea

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: Prebiotic_L, resveratrol_L, Prebiotic_M, Prebiotic_H.
Кому может быть актуально
Состояния в реестре: Irritable Bowel Syndrome - Diarrhoea. Базовые параметры: 18 лет — 60 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
Китай
Следующий шаг
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Обзор

The goal of this clinical trial is to learn if Bifidobacterium. animalis subsp. Lactis A6 Strain or resveratrol to improve the symptoms of diarrhea-predominate irritable bowel syndromes (IBS-D). The main questions it aims to answer are: 1. Does Bifidobacterium animalis subsp.Lactis A6 Strain or resveratrol improve the symptoms of IBS-D. 2. What is the optimal intervention dose of Bifidobacterium. animalis subsp.Lactis A6 Strain or resveratrol to improve IBS-D Researchers will compare Bifidobacterium. animalis subsp.Lactis A6 Strain or resveratrol interventions to placebo (one look-alike sunbstance that contains no interventions substance) to see if Bifidobacterium. animalis subsp.Lactis A6 Strain or resveratrol relief the symptoms of patients with IBS-D. Participants will: 1. Take Bifidobacterium. animalis subsp.Lactis A6 Strain or resveratrol every day for 30 days. 2. Visit the clinic once every 15 days for checkups and tests.

Подробное описание

We recruited patients with IBS-D. The subjects who met the inclusion criteria were randomly divided into placebo control group, Bifidobacterium. animalis subsp.Lactis A6 Strain group and resveratrol intervention. The intervention period lasted for 4 weeks, and the follow-up was conducted every 15 days. The main outcomes were: ① IBS Symptom Severity Scale (IBS-SSS), ② gut microbiota and their metabolites. The secondary outcomes were: ① IBS Quality of Life score (IBS-QOL), ② Bristol fecal traits score, ③hydrogen breath test; ④ Inflammatory markers. After the intervention, statistical analysis was performed on the experimental data to analyze and compare the differences in the main and secondary outcome indicators of the experimental groups, so as to clarify the intervention effect and effective intervention dose of probiotics and resveratrol on diarrheal IBS, and provide scientific basis for the formulation of relevant clinical treatment paths.

Вмешательства

  • Пищевая добавка Prebiotic_L
    subject will receive a low-dosage (1\*10\^5) of Bifidobacterium. animalis subsp.Lactis A6 Strain
  • Пищевая добавка resveratrol_L
    subject will receive a low-dosage (300mg/d) of resveratrol
  • Пищевая добавка Prebiotic_M
    subject will receive a medium-dosage (1\*10\^8) of Bifidobacterium. animalis subsp.Lactis A6 Strain
  • Пищевая добавка Prebiotic_H
    subjects will receive a high-dosage (1\*10\^10) of Bifidobacterium. animalis subsp.Lactis A6 Strain
  • Пищевая добавка resveratrol_H
    subject will receive a low-dosage (600mg/d) of resveratrol
  • Другое placebo_Bif
    subjects will receive placebo (one look-alike sunbstance that contains no prebiotics)
  • Другое placebo_resveratrol
    subjects will receive placebo (one look-alike sunbstance that contains no resveratrol)

Первичные конечные точки

  • Irritable Bowel Syndrome Symptom Severity Scale [Срок оценки: 30 days]
  • IBS Quality of Life [Срок оценки: 30 days]
Вторичные конечные точки (3)
  • The levels of serum inflammatory cytokines, including interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and interleukin-1β (IL-1β). [Срок оценки: 30 days]
  • Concentration of hydrogen in Hydrogen Breath Test [Срок оценки: 30 days]
  • the alpha diversity and composition of gut microbiome [Срок оценки: 30 days]

Критерии участия

Критерии включения

  • met the Western Medicine Rome IV diagnostic criteria for diarrheal IBS
  • 18 and 60 years old
  • subjects voluntarily sign informed consent forms.

Критерии исключения

  • Having a disease that may affect the gut microbiome (e.g., inflammatory bowel disease, celiac disease, diabetes)
  • Abdominal pain or diarrhea due to organic disease
  • Patients with abdominal surgery
  • Patients with serious mental illness and complications of heart, brain, liver, kidney and other systems
  • Unable to communicate normally or skilled in the use of communication equipment
  • Having serious mental problems or taking related drugs
  • Drug or alcohol abusers
  • People with special diets (such as vegetarians) or eating disorders or are receiving therapeutic dietary interventions
  • Had used antibiotics, probiotics, other drugs that may affect the study
  • Participants who are participating in other clinical trials
  • Pregnant or lactating women

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Peking University — Пекин

Идентификаторы

NCT: NCT06779214 · Xuyajun197673-03

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗