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RECRUITINGOBSERVATIONAL

Washed Microbiota Transplantation for Type 1 Diabetes Mellitus

Washed Microbiota Transplantation for Type 1 Diabetes Mellitus: a Real World Research

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: Subjects must meet all of the following inclusion criteria to enter the study: 1. At the time of willing to sign a consent form, 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 willing to sign a consent form, 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. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

OTHER

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.

Locations (1)

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China