Back to resultsClinical Study of Fecal Microbiota Transplantation in the Treatment of Antibiotic-associated Diarrhea
Primary Purpose
Fecal Microbiota Transplantation, Antibiotic-associated Diarrhea
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 Fecal Microbiota Transplantation
Eligibility Criteria
Inclusion Criteria: occurrence of antibiotic-associated diarrhoea; no response to standard therapy; agree to receive FMT and sign informed consent; willingness to provide stool samples. Exclusion Criteria: non-antibiotic-associated diarrhea; did not accept FMT or did not sign informed consent; unwillingness to provide stool samples.
Sites / Locations
- Intestinal Microenvironment Treatment Center of General Surgery, Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FMT group
Arm Description
Outcomes
Primary Outcome Measures
Changes in defecation frequency after FMT.
Changes in gut microbiota after FMT.
Secondary Outcome Measures
Full Information
NCT ID
NCT05990972
First Posted
August 7, 2023
Last Updated
August 7, 2023
Sponsor
Shanghai 10th People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05990972
Brief Title
Clinical Study of Fecal Microbiota Transplantation in the Treatment of Antibiotic-associated Diarrhea
Official Title
To Investigate the Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in the Treatment of Antibiotic-associated Diarrhea.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
July 20, 2020 (Actual)
Primary Completion Date
April 20, 2023 (Actual)
Study Completion Date
July 20, 2023 (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
Antibiotic-associated diarrhea (AAD) refers to the occurrence of other unexplained diarrhea symptoms after the use of antibiotics, often combined with abdominal pain, bloating and bloody stool. Fecal Microbiota Transplantation (FMT) is a therapeutic method to transplant the microbiota from the feces of healthy people into the intestinal tract of patients. To explore the overall efficacy and safety of FMT in the treatment of AAD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Microbiota Transplantation, Antibiotic-associated Diarrhea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FMT group
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Fecal Microbiota Transplantation
Intervention Description
Fecal Microbiota Transplantation (FMT) is a therapeutic method to transplant the microbiota from the feces of healthy people into the intestinal tract of patients. This treatment aims to improve a range of diseases associated with the gut microbiota by restoring the balance of the gut microbiota.
Primary Outcome Measure Information:
Title
Changes in defecation frequency after FMT.
Time Frame
Baseline and three months after treatment
Title
Changes in gut microbiota after FMT.
Time Frame
Baseline and three months after treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
occurrence of antibiotic-associated diarrhoea; no response to standard therapy; agree to receive FMT and sign informed consent; willingness to provide stool samples.
Exclusion Criteria:
non-antibiotic-associated diarrhea; did not accept FMT or did not sign informed consent; unwillingness to provide stool samples.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Le Wang
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
Intestinal Microenvironment Treatment Center of General Surgery, Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University
City
Shanghai
Country
China
12. IPD Sharing Statement
Learn more about this trial
Clinical Study of Fecal Microbiota Transplantation in the Treatment of Antibiotic-associated Diarrhea
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