WMT: Washed microbiota transplantation refers to the infusion of washed microbiota from healthy donor into patients' gastrointestinal tract. Participants will receive three doses of WMT for T1DM.
Study summary
This is a real-world study to explore the safety and the efficacy of washed microbiota transplantation (WMT) for patients with Type 1 Diabetes Mellitus (T1DM).
Eligibility
Sex
ALL
Min age
3 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to enter the study:
1. At the time of informed consent, male or non-pregnant or non-lactating female.
2. The diagnostic criteria for T1DM are confirmed by previous medical record.
3. The subject or his/her legal representative gives informed consent, fully nderstands the purpose of the study, is able to communicate effectively with the investigator, and comprehends and complies with the requirements set forth in the study.
Exclusion Criteria:
Subjects meeting any of the following exclusion criteria must be excluded from the study:
1. Diagnosed as any type of diabetes other than type 1 diabetes mellitus;
2. Subjects with severe life-threatening complications diabetes (such as ketoacidosis, or acute coronary syndrome, etc.);
3. At the time of screening, the subject or his/her legal representative refuses to take effective contraception within 3 months after the last treatment.
4. According to the judgment of the investigator, the subjects are not suitable to participate in this clinical study, or participation in this clinical study cannot guarantee the rights and interests of the subjects.
Primary outcome measure(s)
The mean daily insulin dosage of participants — One-week, Two-week, Four-week post-WMT The mean daily insulin dosage of participants in past week
Trial sites (1)
Facility
City
Region
Status
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing
Jiangsu
Recruiting
More The Second Hospital of Nanjing Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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