Washing and transplanting gut bacteria to help manage Type 1 Diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the safety and efficacy of washed microbiota transplantation (WMT) in patients with Type 1 Diabetes Mellitus (T1DM). A minimum of 20 participants will be enrolled based on specific inclusion criteria, and their demographic data, blood glucose fluctuations, daily insulin dosages, and clinical outcomes will be monitored. Following the treatment, participants will enter a follow-up period to assess the long-term safety and effectiveness of the intervention.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Faming Zhang, PhD — The Second Hospital of Nanjing Medical University
• Study coordinator: Faming Zhang, PhD
• Email: fzhang@njmu.edu.cn
• Phone: 086-025-58509883

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.