Back to resultsDonor Microbiota of Fecal Microbiota Transplantation for CDI
Primary Purpose
Clostridium Difficile Infection, Fecal Microbiota Transplantation
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Fecal microbiota transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Clostridium Difficile Infection
Eligibility Criteria
Inclusion Criteria: aged over 18 years old; positive stool test for Clostridium difficile 16S rDNA and/or glutamate dehydrogenase; can tolerate nasojejunal tube and complete full course of FMT treatment; the clinical data are relatively complete and there is follow-up available for evaluation Exclusion Criteria: accompanied by chronic wasting diseases such as malignant tumor and hyperthyroidism; associated with gastrointestinal organic diseases such as short bowel syndrome, intestinal fistula, and inflammatory bowel disease; c) severe destruction of the intestinal mucosa, severe immunosuppression, combined with severe systemic infection; d) Intervention with antibiotics during treatment
Sites / Locations
- Shanghai Tenth People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
FMT Responder
FMT non-Responder
Arm Description
Outcomes
Primary Outcome Measures
changes of microbiota before and after FMT treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT05703477
First Posted
January 19, 2023
Last Updated
January 27, 2023
Sponsor
Shanghai 10th People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05703477
Brief Title
Donor Microbiota of Fecal Microbiota Transplantation for CDI
Official Title
Dynamic Fluctuation of Donor Microbiota Affects the Prognosis of Fecal Microbiota Transplantation Therapy for Clostridium Difficile Infection
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 10th People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Fecal microbiota transplantation (FMT) achieves the purpose of treating intestinal and extra-intestinal diseases by transplanting the functional microbes in the feces of healthy people into the patient's intestine through the upper or lower alimentary tract routes to rebuild the patient's intestinal microbiota. Recently, FMT has been widely used in the treatment of various gastrointestinal diseases, including but not limit in CDI. In this study, we focused on the demonstration of FMT action mechanism in CDI treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile Infection, Fecal Microbiota Transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FMT Responder
Arm Type
Experimental
Arm Title
FMT non-Responder
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Fecal microbiota transplantation
Intervention Description
Fecal microbiota transplantation (FMT) achieves the purpose of treating intestinal and extra-intestinal diseases by transplanting the functional microbes in the feces of healthy people into the patient's intestine through the upper or lower alimentary tract routes to rebuild the patient's intestinal microbiota.
Primary Outcome Measure Information:
Title
changes of microbiota before and after FMT treatment
Time Frame
7 days, 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
aged over 18 years old;
positive stool test for Clostridium difficile 16S rDNA and/or glutamate dehydrogenase;
can tolerate nasojejunal tube and complete full course of FMT treatment;
the clinical data are relatively complete and there is follow-up available for evaluation
Exclusion Criteria:
accompanied by chronic wasting diseases such as malignant tumor and hyperthyroidism;
associated with gastrointestinal organic diseases such as short bowel syndrome, intestinal fistula, and inflammatory bowel disease; c) severe destruction of the intestinal mucosa, severe immunosuppression, combined with severe systemic infection; d) Intervention with antibiotics during treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongliang Tian
Organizational Affiliation
Intestinal Microenvironment Treatment Center of General Surgery, Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Tenth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200071
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Donor Microbiota of Fecal Microbiota Transplantation for CDI
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