NCT06106698

Washed Microbiota Transplantation for Clostridioides Difficile Infection

Washed Microbiota Transplantation for Clostridioides Difficile Infection: a Real World Research

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (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 Clostridioides Difficile Infection （CDI）.

Detailed description

At least 12 subjects who meet all the inclusion criteria but do not meet any exclusion criteria will be enrolled in this study. Data of demographic characteristics, intestinal symptoms, medicine treatment usage and clinical outcomes will be collected. After treatment, they will enter the follow-up period （at least for 4-week post-WMT）for safety and efficacy evaluation. Subjects with no response and recurrence will receive salvage therapy, and the extended follow-up period will be performed.

Conditions

• Clostridioides Difficile Infection

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 one dose of WMT for CDI. During follow-up, those who have non-response or CDI recurrence within 4-week post-WMT will receive rescue WMT.

Timeline

• Start date: 2023-07-22
• Primary completion: 2029-07-01
• Completion: 2029-12-01
• First posted: 2023-10-30
• Last updated: 2023-10-30

Locations

1 site across 1 country: China