Efficacy and Safety of Fecal Microbiota Transplantation
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: Fecal Microbiota Transplantation.
- Кому может быть актуально
- Состояния в реестре: Fecal Microbiota Transplantation. 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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Официальное название
Efficacy and Safety of Fecal Microbiota Transplantation in Patients With Intestinal Dysbiosis -A Pilot Study
Обзор
In recent years, researches illustrate that multifactorial diseases such as functional gastrointestinal disorders, autoimmune diseases, metabolic, behavioral and neurological diseases are associated with an abnormal microbiome structure-dysbiosis, which means the imbalance of the microbiome community. Fecal microbiota transplantation (FMT), the infusion of faeces from a healthy donor to the gastrointestinal tract of a recipient patient aiming to alter the intestine microbiota, is recommended to be performed in Clostridium difficile infection(CDI) as the most effective therapy. It also being used experimentally in the treatment of the disease states linked to dysbiosis of the intestinal microbiota. However, the efficacy and safety of FMT to treat the dysbiosis-associated diseases is still in its infancy. To further verify the indications above, more data is required to be collected through studies.
Вмешательства
- Процедура Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
Первичные конечные точки
- The efficacy of FMT in patients with gastrointestinal symptom will be assessed by the change of Gastrointestinal Symptom Rating Scale(GSRS). [Срок оценки: 1 year]
Вторичные конечные точки (1)
- Number of Participants With Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events(CTCAE) V4.0 [Срок оценки: 1 year]
Критерии участия
Критерии включения
Confirmed diagnosis of any of following diseases:
- Irritable Bowel Syndrome
- Ulcerative colitis
- Crohn's disease
- Constipation
- Clostridium Difficile Infection
- Functional Dyspepsia
- Parkinson's Disease
- Metabolic Syndrome
- Non-Alcoholic Fatty Liver Disease
- Autism Spectrum Disorder
- Radiation Enteritis
- Atopic Dermatitis
- Food Allergic
- Graft-versus-Host Disease
- Obesity
- Diabetes mellitus
- Multi-Drug Resistant Infection
- Hepatic Encephalopathy
- Enteric Dysbacteriosis
- Multiple Sclerosis
- Pseudomembranous Enteritis
- Acute Pancreatitis
- Chronic Fatigue Syndrome
- Acute-on-chronic Liver Failure with HBV Infection
- Alcoholic Liver Disease
- Anorexia
- Decompensated Cirrhosis
- Henoch-Schonlein Purpura
- Autoimmune Liver Disease
- Systemic Lupus Erythematosus
- Rheumatoid arthritis
- IgG4-Related Disease
- Celiac Disease
- Protein-losing Enteropathy
- Asperger Syndrome
- Rheumatoid arthritis
- Psoriasis
- Ankylosing spondylitis
- Immune checkpoint inhibition-related colitis
- Autoimmune enteropathy
- Drug-induced diarrhea
- Suffering from gastrointestinal symptoms such as constipation, diarrheas, abdominal pain, flatulence, etc.
- The participants must be able to tolerate the FMT infusion method such as endoscopy, colonoscopy, capsule, nasoduodenal tube insertion, etc.
Критерии исключения
- Current pregnancy or breast-feeding;
- Suffering from other severe diseases, including liver or kidney failure, heart failure, MODS, coma, cerebrovascular accident;
- Known contraindication to all FMT infusion method such as nasoduodenal tube insertion, endoscopy, colonoscopy and enema;
- Any conditions that may render the efficacy of FMT or at the discretion of the investigators.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Нерандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Китай · 1 центр
- Guangzhou First People's Hospital — Гуанчжоу
Публикации
- Levy M, Kolodziejczyk AA, Thaiss CA, Elinav E. Dysbiosis and the immune system. Nat Rev Immunol. 2017 Apr;17(4):219-232. doi: 10.1038/nri.2017.7. Epub 2017 Mar 6. PMID 28260787
- Brandt LJ. American Journal of Gastroenterology Lecture: Intestinal microbiota and the role of fecal microbiota transplant (FMT) in treatment of C. difficile infection. Am J Gastroenterol. 2013 Feb;108(2):177-85. doi: 10.1038/ajg.2012.450. Epub 2013 Jan 15. PMID 23318479
- Paramsothy S, Kamm MA, Kaakoush NO, Walsh AJ, van den Bogaerde J, Samuel D, Leong RWL, Connor S, Ng W, Paramsothy R, Xuan W, Lin E, Mitchell HM, Borody TJ. Multidonor intensive faecal microbiota transplantation for active ulcerative colitis: a randomised placebo-controlled trial. Lancet. 2017 Mar 25;389(10075):1218-1228. doi: 10.1016/S0140-6736(17)30182-4. Epub 2017 Feb 15. PMID 28214091
- Ooijevaar RE, Terveer EM, Verspaget HW, Kuijper EJ, Keller JJ. Clinical Application and Potential of Fecal Microbiota Transplantation. Annu Rev Med. 2019 Jan 27;70:335-351. doi: 10.1146/annurev-med-111717-122956. Epub 2018 Nov 7. PMID 30403550
- Lee P, Yacyshyn BR, Yacyshyn MB. Gut microbiota and obesity: An opportunity to alter obesity through faecal microbiota transplant (FMT). Diabetes Obes Metab. 2019 Mar;21(3):479-490. doi: 10.1111/dom.13561. Epub 2018 Nov 20. PMID 30328245
- Bajaj JS, Kassam Z, Fagan A, Gavis EA, Liu E, Cox IJ, Kheradman R, Heuman D, Wang J, Gurry T, Williams R, Sikaroodi M, Fuchs M, Alm E, John B, Thacker LR, Riva A, Smith M, Taylor-Robinson SD, Gillevet PM. Fecal microbiota transplant from a rational stool donor improves hepatic encephalopathy: A randomized clinical trial. Hepatology. 2017 Dec;66(6):1727-1738. doi: 10.1002/hep.29306. Epub 2017 Oct 3 PMID 28586116
- Sun MF, Zhu YL, Zhou ZL, Jia XB, Xu YD, Yang Q, Cui C, Shen YQ. Neuroprotective effects of fecal microbiota transplantation on MPTP-induced Parkinson's disease mice: Gut microbiota, glial reaction and TLR4/TNF-alpha signaling pathway. Brain Behav Immun. 2018 May;70:48-60. doi: 10.1016/j.bbi.2018.02.005. Epub 2018 Feb 20. PMID 29471030
- Johnsen PH, Hilpusch F, Cavanagh JP, Leikanger IS, Kolstad C, Valle PC, Goll R. Faecal microbiota transplantation versus placebo for moderate-to-severe irritable bowel syndrome: a double-blind, randomised, placebo-controlled, parallel-group, single-centre trial. Lancet Gastroenterol Hepatol. 2018 Jan;3(1):17-24. doi: 10.1016/S2468-1253(17)30338-2. Epub 2017 Nov 1. PMID 29100842
Идентификаторы
NCT: NCT04706611 · B-2019-041-01