NCT06256614

Washed Microbiota Transplantation for Type 1 Diabetes Mellitus

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: The Second Hospital of Nanjing Medical University · Academic / Other
• Sex: All
• Age: 3 Years – 100 Years
• Healthy volunteers: Not accepted

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).

Detailed description

At least 20 subjects who meet all the inclusion criteria but do not meet any exclusion criteria will be enrolled in this study. Data of demographic characteristics, blood glucose fluctuation and variability, daily insulin dosage and clinical outcomes will be collected. After treatment, they will enter the follow-up period for safety and efficacy evaluation.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-03-01
• Primary completion: 2029-01-01
• Completion: 2029-07-01
• First posted: 2024-02-13
• Last updated: 2025-09-10

Locations

1 site across 1 country: China