Washed Microbiota Transplantation for Clostridioides Difficile Infection

October 24, 2023 updated by: The Second Hospital of Nanjing Medical University

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

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）.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210011
        • Recruiting
        • The Second Affiliated Hospital of Nanjing Medical University
        • Contact:
          • Jie Zhang
          • Phone Number: 58509931

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

National patients with CDI receiving WMT will be enrolled.

Description

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 exclusion criteria must be excluded from the study:

  1. Subjects with immune deficiencies (such as HIV infection, or neutrophils <0.5×109/L in absolute value, or lymphocytes <0.5×109/L, etc.), or on immunosuppressants, or on medium to high doses of steroid hormones (≥20g/d of prednisone or equal doses of steroid hormones).
  2. There is rectal outlet obstruction (such as rectal mucosal prolapse) or significant intestinal stenosis assessed by the investigator and colonic transendoscopic enteral tubing cannot be performed.
  3. Confirmed or clinically suspected infection with pathogenic microorganisms other than Clostridium difficile prior to screening.
  4. Have had major abdominal surgery (other than laparoscopic gallbladder or appendectomy), previous partial or total colectomy, previous partial small intestinal resection, or previous gastroduodenal surgery within 6 months prior to screening.
  5. At the time of screening, the subject or his/her legal representative refuses to take effective contraception within 3 months after the last treatment.
  6. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0
Time Frame: 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.).
Four-week post-WMT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The complete response rate of CDI-related diarrhea
Time Frame: 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.
Four-week post-WMT，eight-week post-WMT
Recurrence rate of CDI-related diarrhea.
Time Frame: 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.
Four-week post-WMT，eight-week post-WMT
Rate of major disease progression in CDI.
Time Frame: 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.
One-week post-WMT，Two-week post-WMT
The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0
Time Frame: 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.).
Eight-week post-WMT，six-month-post-WMT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Hospital of Nanjing Medical University

Investigators

  • Principal Investigator: Faming Zhang, The Second Hospital of Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2023

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

October 12, 2023

First Submitted That Met QC Criteria

October 24, 2023

First Posted (Actual)

October 30, 2023

Study Record Updates

Last Update Posted (Actual)

October 30, 2023

Last Update Submitted That Met QC Criteria

October 24, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WMT-RWS-CDI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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