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).
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.
Study Type
OBSERVATIONAL
Enrollment
100
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.
The second affiliated hospital of Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGThe incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0
The severity of AE was graded as mild (grade 1), moderate (grade 2), severe/disabling (grade 3), life threatening (grade 4), and death (grade 5). All AE were divided in definitely, probably and possibly related to treatment. The treatment-related AE we focused on included microbiota-related AEs (e.g., infection, diarrhea, abdominal pain, etc.) and route of delivery related AEs (e.g., nausea, vomiting, etc.).
Time frame: Four-week post-WMT
The complete response rate of CDI-related diarrhea
The complete response of CDI-related diarrhea was defined as there was no diarrhea (1-2 times/day) for at least two consecutive days (normal stool characteristics (Bristol score ≤5) after treatment.
Time frame: Four-week post-WMT,eight-week post-WMT
Recurrence rate of CDI-related diarrhea.
Recurrence was defined as the CDI-related diarrhea reappeared, and the Clostridium difficile toxin test was positive after achieving complete response.
Time frame: Four-week post-WMT,eight-week post-WMT
Rate of major disease progression in CDI.
Disease progression refers to the worsening of symptoms associated with CDI, including increased diarrhea, toxic megacolon, organ failure, the need for emergency colectomy, and even death.
Time frame: One-week post-WMT,Two-week post-WMT
The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0
The severity of AE was graded as mild (grade 1), moderate (grade 2), severe/disabling (grade 3), life threatening (grade 4), and death (grade 5). All AE were divided in definitely, probably and possibly related to treatment. The treatment-related AE we focused on included microbiota-related AEs (e.g., infection, diarrhea, abdominal pain, etc.) and route of delivery related AEs (e.g., nausea, vomiting, etc.).
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Time frame: Eight-week post-WMT,six-month-post-WMT