Clostridioides Difficile Infection
Conditions
Keywords
washed microbiota transplantation, Clostridioides Difficile Infection, Intestinal infection, Antibiotic-associated Diarrhea
Brief 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.
Interventions
OTHERWMT
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.
Sponsors
The Second Hospital of Nanjing Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Years to 100 Years
Healthy volunteers
No
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 C. difficile infection are met during screening: 1. Medical records confirming CDI prior to screening (laboratory tests are positive for Clostridium difficile or its toxin): Clostridium difficile toxin test is positive (determined by EIisa test), or colonoscopy indicates pseudomembranous enteritis; Or Glutamate dehydrogenase positive, toxin negative, there are obvious causes and diarrhea. 2. CDI-related diarrhea episodes, i.e., defecation ≥3 times/day for at least two consecutive days with unformed stools (Bristol score 6-7). 3. The subject or his/her legal representative gives informed consent, fully understands 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0 | Four-week post-WMT | 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.). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The complete response rate of CDI-related diarrhea | Four-week post-WMT，eight-week post-WMT | 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. |
| Recurrence rate of CDI-related diarrhea. | Four-week post-WMT，eight-week post-WMT | Recurrence was defined as the CDI-related diarrhea reappeared, and the Clostridium difficile toxin test was positive after achieving complete response. |
| Rate of major disease progression in CDI. | One-week post-WMT，Two-week post-WMT | 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. |
| The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0 | Eight-week post-WMT，six-month-post-WMT | 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.). |
Countries
China
Contacts
Primary ContactFaming Zhang, PhD
Backup ContactBota Cui
Outcome results
None listed