Washing and transplanting gut bacteria to help manage Type 1 Diabetes
Washed Microbiota Transplantation for Type 1 Diabetes Mellitus: a Real World Research
This study is testing whether washing and transplanting gut bacteria can help people with Type 1 Diabetes manage their blood sugar levels better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 3 Years to 100 Years |
| Sex | All |
| Sponsor | The Second Hospital of Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06256614 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with Type 1 Diabetes Mellitus who meet the inclusion criteria.
Not a fit: Patients with other types of diabetes or severe complications related to diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved glycemic control and reduced insulin requirements for patients with Type 1 Diabetes.
How similar studies have performed: While the concept of microbiota transplantation is gaining interest, this specific approach for Type 1 Diabetes is relatively novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Nanjing, Jiangsu
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.