Fecal microbiota transplantation (FMT), defined as infusion of feces from healthy donors to affected subjects, is a method to restore a balanced gut microbiota and has attracted great interest in recent years due to its efficacy and ease of use.
FMT is now recommended as the most effective therapy for CDI not responding to standard therapies1.Recent studies have suggested that dysbiosis is associated with a variety of disorders, and that FMT could be a useful treatment. Randomized controlled trial has been conducted in a number of disorders including ulcerative colitis (UC). Our study is aims to Fecal microbiota transplantation in the treatment of Inflammatory Bowel Disease, the role of selection of the Dai ethnic group as donor source in terms of treatment efficacy and pathogenic mechanisms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
240
transplant infusion of feces from healthy donors into affected subjects
Endoscopy
Kunming, Yunnan, China
steroid-free clinical remission and endoscopic remission
The primary outcome is a composite of steroid-free clinical remission together with endoscopic remission or response at week 6, defined as defined as a total Mayo score of ≤2 points with no individual sub-score \>1 point, and at least a 1 point reduction from baseline in the endoscopy sub-score
Time frame: 3 years
Steroid-free clinical remission
defined as combined Mayo sub-scores of 1 or less for rectal bleeding plus stool frequency
Time frame: 3 years
Steroid-free clinical response
defined as either a decrease of 3 points or more on the Mayo score, a 50% or greater reduction from baseline in combined rectal bleeding plus stool frequency Mayo sub-scores, or both
Time frame: 3 years
Steroid-free endoscopic response
defined as a Mayo endoscopy sub-score of 1 or less, with a reduction of at least 1 point from baseline
Time frame: 3 years
microbiological change
Changes in microbial composition (including bacteriome, virome and fungome), function and metabolite
Time frame: 3 years
Change in microbiome of stool
Change in microbiome of stool (including bacteriome, virome and fungome)
Time frame: 3 years
Difference in microbiome compared between subjects in different treatment arm
Difference in microbiome (including bacteriome, virome and fungome) compared between subjects in different treatment arm
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Time frame: 3 years
Proportion of microbiome
Proportion of microbiome (including bacteriome, virome and fungome) derived from recipient, donor or both in subjects who received FMT
Time frame: 3 years
Difference in microbiome compared between subjects who have weight loss and those do not have weight loss
Difference in microbiome (including bacteriome, virome and fungome) compared between subjects who have weight loss and those do not have weight loss
Time frame: 3 years
Microbial factors that are associated with percentage of body weight loss
Microbial factors (including bacteriome, virome and fungome) that are associated with percentage of body weight loss
Time frame: 3 years
Trans-kingdom correlation of microbial engraftment after FMT between bacteriome, virome and fungome
Trans-kingdom correlation of microbial engraftment after FMT between bacteriome, virome and fungome
Time frame: 3 years