The Safety and Efficacy of Fecal Microbiota Transplantation in the Treatment of Digestive Diseases and Non-digestive System Diseases Associated With Gastrointestinal Symptoms in the Gastrointestinal Tract.
1 other identifier
interventional
10,000
1 country
1
Brief Summary
The exploration of the safety and efficacy of fecal microbiota transplantation in the treatment of non-digestive system diseases associated with gastrointestinal symptoms in the gastrointestinal tract, while also investigating the impact of fecal microbiota transplantation on the intestinal system, and assessing the improvement of symptoms in other systems.Simultaneously optimizing the conditions during the FMT process, identifying the most effective treatment methods to enhance the therapeutic outcomes of FMT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2018
Longer than P75 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 10, 2018
CompletedFirst Submitted
Initial submission to the registry
January 7, 2024
CompletedFirst Posted
Study publicly available on registry
January 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2025
CompletedJanuary 24, 2024
January 1, 2024
7.9 years
January 7, 2024
January 23, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Comparing the therapeutic efficacy of patients after FMT.
Through conducting relevant questionnaire surveys with patients, we can gain insights into the therapeutic efficacy of patients after undergoing FMT.
0day, 7days, 30days, 3 months, 6months,12 months
Comparing the differences in microbiota composition in samples such as feces and small intestinal fluid from patients.
Performing 16S rRNA sequencing, metagenomic sequencing, and metabolite analysis on the samples.
0day, 7days, 30days, 3 months, 6months,12 months
Study Arms (1)
FMT group
EXPERIMENTALInterventions
Fecal microbiota transplantation (FMT) is a method for treating imbalances in the intestinal microbiota. Its basic principle involves extracting a portion of feces from a healthy individual that contains a diverse population of beneficial bacteria, processing it, and transplanting it into the digestive system of the recipient to restore a balanced intestinal microbiota.
Eligibility Criteria
You may qualify if:
- Being able to tolerate a nasoenteric tube or swallow a capsule.
You may not qualify if:
- Intestinal barrier dysfunction. Inability to tolerate enteral nutrition.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Le Wang
Shanghai, Shanghai Municipality, 200040, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dean of the hospital
Study Record Dates
First Submitted
January 7, 2024
First Posted
January 17, 2024
Study Start
January 10, 2018
Primary Completion
December 10, 2025
Study Completion
December 10, 2025
Last Updated
January 24, 2024
Record last verified: 2024-01