Inflammatory bowel disease (IBD) is a chronic, recurrent, non-specific intestinal disease, including ulcerative colitis (UC) and Crohn's disease (CD). Although biological therapy significantly improved the effect of the treatment of ulcerative colitis, but nearly two-thirds of the patient's response to drug treatment. Therefore, new treatments targeting the underlying pathophysiology of UC are critical. Given that alterations in the gut microbiome are strongly associated with disease activity in IBD, many studies have proposed microbiotoy-based therapies, in particular, Fecal microbiota transplantation (FMT) in the treatment of UC. Donor-to-donor variation in treatment with fecal microbiota transplantation may alter treatment efficacy. Therefore, screening high-quality donors can improve efficacy and minimize the risk of adverse effects.
Ulcerative colitis with the changes in the gut microbiota and biodiversity decrease and the change of the relative abundance of advantage bacterium group, a significant reduction in UC patients with intestinal flora diversity, at the species level, thick wall bacteria door bacteria (e.g., clostridium tender) ratio decreases, actinomyces door, the door deformation bacteria such as e. coli), enterobacteriaceae, streptococcus, bacteroides ratio increased.A previous study by team of the investigators found that there were ethnic and regional differences in the incidence of IBD in Yunnan Province, and the incidence of Dai, Bai and Miao was lower than that of Han. Then the related factors were analyzed, among which, the ethnic characteristic diet of Yunnan ethnic minorities can improve the diversity of intestinal flora and viruses, increase the content of probiotics, and is a protective factor for the low incidence of UC.Based on this, donor-to-donor variation in the treatment of fecal microbiota transplantation may alter the therapeutic effect. Therefore, screening high-quality donors can improve efficacy and minimize the risk of adverse effects.Based on this, the investigators asked scientific questions: FMT in the treatment of IBD: the Bai nationality of Yunnan province may be a high quality donor.Our study is aims to FMT in the treatment of IBD, the role of selection of the Bai nationality as donor source in terms of treatment efficacy and mechanisms.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Transplantation of fresh fecal bacterial fluid into the ileocecum of patients with ulcerative colitis via the colonoscopic route
China
Kunming, Yunnan, China
endoscopic remission or response
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: 8 to 12 weeks after fecal microbiota transplantation
Steroid-free clinical remission
combined Mayo sub-scores of 1 or less for rectal bleeding plus stool frequency
Time frame: 8 to 12 weeks after fecal microbiota transplantation
Steroid-free clinical response
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: 8 to 12 weeks after fecal microbiota transplantation
Steroid-free endoscopic response
a Mayo endoscopy sub-score of 1 or less, with a reduction of at least 1 point from baseline
Time frame: 8 to 12 weeks after fecal microbiota transplantation
Changes in microbial
composition,function and metabolite
Time frame: 0、1、8、12 weeks after fecal microbiota transplantation
Difference in microbiome compared between subjects in different treatment arms
Difference in microbiome compared between subjects in different treatment arms
Time frame: 0、1、8、12 weeks after fecal microbiota transplantation
Proportion of microbiome derived from recipient, donor or both in subjects who received FMT
Proportion of microbiome derived from recipient, donor or both in subjects who received FMT
Time frame: 0、1、8、12 weeks after fecal microbiota transplantation
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