Clinical Trial

Efficacy and Safety of Fecal Microbiota Transplantation

Study acronym: FMT
Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated April 8, 2021 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
In recent years, researches illustrate that multifactorial diseases such as functional gastrointestinal disorders, autoimmune diseases, metabolic, behavioral and neurological diseases are associated with an abnormal microbiome structure-dysbiosis, which means the imbalance of the microbiome community. Fecal microbiota transplantation (FMT), the infusion of faeces from a healthy donor to the gastrointestinal tract of a recipient patient aiming to alter the intestine microbiota, is recommended to be performed in Clostridium difficile infection(CDI) as the most effective therapy. It also being used experimentally in the treatment of the disease states linked to dysbiosis of the intestinal microbiota. However, the efficacy and safety of FMT to treat the dysbiosis-associated diseases is still in its infancy. To further verify the indications above, more data is required to be collected through studies.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2021-01-10; most recent amendment 2021-04-06.
Status change: Not Yet Recruiting → Recruiting 2021-02-01
Trial Details
NCT Number NCT04706611
Lead Sponsor Guangzhou First People's Hospital
Conditions Fecal Microbiota Transplantation
Enrollment 300 participants
Start Date 2021-01-15
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2021-04-08