Efficacy and Safety Evaluation of Fecal Microbiota Transplantation in Irritable Bowel Syndrome
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: Irritable Bowel Syndrome. 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 →
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Обзор
Participants will be given FMT through oral capsules or nasojejunal tube once a month. After three-time treatment, participants were followed up for three months. Participants complete specific scales to assess improvement in symptoms, emotion and quality of life. Besides, they report adverse effects and collect fecal samples at each visit.
Подробное описание
This prospective, single-arm interventional study aims to evaluate efficacy and safety of fecal microbiota transplantation in refractory IBS patients. Patients meeting the inclusion and exclusion criteria will provide written informed consent and receive FMT from healthy donors for three times. The administration methods include taking oral capsule or delivering microbiota suspension into the duodenum via nasojejunal tube. The patients receive treatment once a month and will be followed up for 3 months. Improvement in IBS symptoms, emotion and quality of life were assessed through IBS symptom severity scale (IBS-SSS), Gastrointestinal symptom rating scale (GSRS), IBS-Global Assessment of Improvement (IBS-GAI), Self-rating Anxiety Scale (SAS), Self-rating Depression Scale (SDS) and IBS-Quality of Life (IBS-QoL) respectively. Patients were asked to complete these scales and collect fecal samples at baseline, post-FMT and at 1, 2, 3 and 4 months after FMT. Primary endpoints were improvement in IBS-SSS score and global symptoms after three-time FMT. Secondary endpoints include Change in GSRS score, improvement in emotion and quality of life at post-FMT, 1 and 6 months, as well as change in fecal microbiota composition.
Вмешательства
- Другое FMT
FMT refers to transplanting healthy donor-derived microbiota to participants via oral capsule or injection of fecal suspension via nasojejunal tube.
Первичные конечные точки
- Change from baseline IBS symptom severity scale (IBS-SSS) score at 9 weeks [Срок оценки: at baseline and 9 weeks]
- Response rate at 9 weeks [Срок оценки: at 9 weeks]
Вторичные конечные точки (8)
- Change from baseline IBS symptom severity scale (IBS-SSS) score at 1 week, 1 month and 6 months [Срок оценки: at baseline, 1 week, 1 month and 6 months]
- Change from baseline Gastrointestinal Symptom Rating Scale (GSRS) score at 1 week, 1 month, 9 weeks and 6 months [Срок оценки: at baseline, 1 week, 1 month, 9 weeks and 6 months]
- Change from baseline IBS-Quality of Life (IBS-QoL) score at 1 month, 3 months and 6 months [Срок оценки: at baseline, 1 month, 3months and 6 months]
- Change from baseline Self-rating Anxiety Scale (SAS) score at 1 month, 3 months and 6 months [Срок оценки: at baseline, 1 month, 3months and 6 months]
- Change from baseline Self-rating Depression Scale (SDS) score at 1 month, 3 months and 6 months [Срок оценки: at baseline, 1 month, 3months and 6 months]
- Response rate at 1 week, 1month, 3 months and 6 months [Срок оценки: at 1 week, 1month, 3 months and 6 months]
- Change from baseline fecal microbiota composition at 1 week, 1 month and 6 months [Срок оценки: at baseline, 1 week, 1 month and 6 months]
- Change from baseline fecal metabolites at 1 week, 1 month and 6 months [Срок оценки: at baseline, 1 week, 1 month and 6 months]
Критерии участия
Критерии включения
- Patients who fulfilled the Rome IV criteria for the diagnosis of IBS, aged 18-70 years;
- Patients who have experienced failure of at least 3 conventional therapies for IBS;
- Absence of red flags such as weight loss, hematochezia;
Критерии исключения
- Pregnant, planning pregnancy or lactating;
- Psychiatric disorder or unable to cooperate with treatment and follow-up visit;
- Immunodeficiency or treatment with immune-modulating medication;
- Use of probiotics within the previous 3 months or treatment with antibiotics within 1 month prior to study entry;
- Having undergone any abdominal surgery, with the exception of appendectomy, cholecystectomy, caesarean section and hysterectomy;
- Presence of uncontrolled diabetes, hypertension, thyroid disease or other systemic disease;
- Presence of severe diseases related to heart, brain, kidney and lung or concomitant malignancies;
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
- Лечение
Центры проведения
Китай · 1 центр
- Zhongshan Hospital, Fudan University — Шанхай
Идентификаторы
NCT: NCT05740319 · B2022-507R