Меню
Идёт набор NCT07387952

The Safety and Efficacy of Fecal Microbiota Transplantation Combined With Nutritional Intervention in the Treatment of Functional Constipation：a Pilot Study

Без фазы С лечением Constipation - Functional Fecal Microbiota Transplantation (FMT) Chronic Constipation

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: FMT.
Кому может быть актуально
Состояния в реестре: Constipation - Functional, Fecal Microbiota Transplantation (FMT), Chronic Constipation. Базовые параметры: 18 лет — 70 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
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 →

Обзор

Chronic constipation is a common gastrointestinal disease with a global prevalence of about 15%, significantly affecting daily life and quality of life. Traditional treatments primarily rely on laxatives, which may lead to adverse effects with prolonged use, while surgical interventions have limited patient acceptance. Recent studies indicate that gut microbiota therapies-including probiotics, prebiotics, synbiotics, postbiotics, and fecal microbiota transplantation (FMT)-can effectively manage chronic constipation. This study aims to investigate the safety and efficacy of FMT combined with a prebiotic nutritional intervention (using a co-localization strategy) in the treatment of functional constipation. Additionally, the investigators will explore changes in fecal microbiota and metabolomic profiles following the treatment.

Вмешательства

  • Процедура FMT
    In this group, colonoscopy is performed and a colostomy is placed in the ileocecal region. Bacterial infusion is performed for 3 days with 100ml graft per day. Within 30 minutes after receiving the microbiota transplantation, take the high dietary fiber preparation and dissolve it in water according to the instructions. Blood, stool, and colonoscopy-derived mucosal samples are collected before and after FMT and Researchers conduct follow-ups.

Первичные конечные точки

  • Frequency of Defecation (Spontaneous Bowel Movements) [Срок оценки: Baseline, Weeks 4, 8, 12, 18, and 24]
  • Stool Consistency Assessed by Bristol Stool Form Scale (BSFS) [Срок оценки: Baseline, Weeks 4, 8, 12, 18, and 24]
  • Severity of Defecation Straining [Срок оценки: Baseline, Weeks 4, 8, 12, 18, and 24]
Вторичные конечные точки (2)
  • Incidence of Treatment-Emergent Adverse Events [Срок оценки: From baseline through Week 24]
  • Change in Gut Microbiota Composition Assessed by Metagenomic Sequencing [Срок оценки: Baseline, Weeks 2, 4, 8, 12, 18, and 24]

Критерии участия

Критерии включения

  • Age: 18 to 70.
  • Diagnostic criteria: Functional constipation (FC) in accordance with Rome IV criteria, which should meet the following conditions:
  • Symptom requirements: The following at least 2 items should occur in ≥25% of bowel movements: a. Straining during defecation; b. Hard stool (Bristol Stool Classification score 1-2); c. Feeling of incomplete evacuation; d. Rectal obstruction sensation; e. Need for finger assistance during defecation; f. Spontaneous bowel movements <3 times per week.
  • It is rare to have loose stools without laxatives.
  • Exclusion of irritable bowel syndrome (IBS): IBS diagnosis criteria not meeting Rome IV.
  • Disease course requirements: Symptoms persist for at least 6 months and meet the above criteria within the last 3 months.
  • Traditional treatment methods (dietary intervention, at least two laxatives or probiotics) are ineffective.

Критерии исключения

  • Pregnancy or lactation.
  • Unable to take the intervention product or complete the examination as required.
  • Language expression disorder or mental illness.
  • Physical examination showed severe liver and kidney dysfunction.
  • Acute gastrointestinal disease within 4 weeks.
  • Constipation caused by surgery in the past 4 weeks.
  • History or abnormal examination: cancer, severe enteritis, intestinal obstruction, inflammatory bowel disease, hypothyroidism, mental illness, stroke, heart disease, cirrhosis, renal failure, hematopoietic system diseases, organic bowel disease suggested by colonoscopy or imaging.
  • Participation in other clinical trials within 3 months prior to enrollment.
  • Other health problems are not suitable for participation in the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Peking Union Medical College Hospital — Пекин

Идентификаторы

NCT: NCT07387952 · I-25PJ1600

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗