Specified clinical trial for fecal microbiota transplantation and gut microbiota reconstruction in patients with refractory diarrhea

未提供0 个研究点目标入组 10 人开始时间: 2023年6月6日最近更新: 2024年8月1日

试验速览

暂无简介。

•Study subject:
•(1) Aged 18 years or older at informed consent.
•(2) Patient with prolonged diarrhea more than 10 days despite of standard treatment for diarrhea, or who continue to have diarrhea without using antidiarrheal drugs.
•(3) Patient with dysbiosis in the gut assessed using stool smear.
•(4) Patient with written consent to participate in this study from the patient or his/her surrogate.
•(1) Aged 18-70 years (If possible, relatives of the study subject).
•(2) Patient without dysbiosis in the gut assessed using stool smear.
•(3) If the study subject has a food allergy, person who is possible not to consume the food for at least 5 days before stool collection.
•(4) Person with written consent from the person regarding the implementation of interview and various tests specified in this study and the provision of stool.

•Study subject:
•(1) Patient with shock (blood lactate level 18 mg/dL or higher) or who using catecholamines.
•(2) Patient with severe immunodeficiency <500 / microL of neutrophils.
•(3) Patient who cannot expect a prognosis of 3 months or more even if diarrhea have subsided.
•(4) Patient who are judged by the investigator to be inappropriate as research subjects for other reasons.
•(1) Person suspected to have infection by interviewing and screening for blood and stool tests, or who have disease that should be excluded.
•Excluded diseases: inflammatory bowel disease, irritable bowel syndrome, chronic diarrhea, severe constipation, malignant tumor under treatment, autoimmune disease, severe obesity, Parkinson's disease, autism, depression, Creutzfeldt-Jakob's disease.
•For cytomegalovirus and EB virus, when the study subject is not infected, if the donor's screening test result is positive, it is non-eligible.
•(2) Parson who are judged by the investigator to be inappropriate as doner for other reasons

Adverse events

发起方

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