The Dynamic Fluctuation of Donor Microbiota Affects the Prognosis of Fecal Microbiota Transplantation for C. Difficile Infection
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2022
CompletedFirst Submitted
Initial submission to the registry
January 19, 2023
CompletedFirst Posted
Study publicly available on registry
January 30, 2023
CompletedJanuary 12, 2024
January 1, 2024
2.7 years
January 19, 2023
January 10, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
changes of microbiota before and after FMT treatment
7 days, 1 month
Study Arms (2)
FMT Responder
EXPERIMENTALFMT non-Responder
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200071, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hongliang Tian
Intestinal Microenvironment Treatment Center of General Surgery, Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University
Study Record Dates
First Submitted
January 19, 2023
First Posted
January 30, 2023
Study Start
January 1, 2020
Primary Completion
August 30, 2022
Study Completion
August 30, 2022
Last Updated
January 12, 2024
Record last verified: 2024-01