Fecal microbiota transplantation (FMT) is a strategy that infuses a fecal suspension containing a healthy donor's microbiota into a patient's gut to restore his/her intestinal microbiome. Fecal microbiota transplantation has been used for several disease，but the efficacy of ulcerative colitis(UC) by fecal microbiota transplantation needs to be further explored.The investigators propose to determine the efficiency and safety of FMT in patients with ulcerative colitis(UC).
The present clinical trial aims to re-establish a gut functionality state of intestinal flora through FMT as a therapy for ulcerative colitis(UC). We established a standard microbiota isolation from donated fresh stool in lab. Then the microbiota is transplanted to the intestine. Patients from Guangzhou First People's Hospital in this study will be assigned to receive FMT at least two times according to associated guidelines and follow-up for at least three months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
200 mL of prepared fecal microbiota suspension from healthy donors' fresh feces was injected into the intestine
Infusion of Saline
Mesalazine and/or Prednisone
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
RECRUITINGClinical remission in patient as assessed using Mayo score
Total Mayo score less than 2 and no signal item more than 1
Time frame: 12 weeks
Clinical improvement in patient as assessed using Mayo score
Total Mayo score decreased more than 3
Time frame: 12 weeks
Intestinal microbiota changing
The change of intestinal microbiota composition after FMT compared with subject original microbiota and donor's microbiota
Time frame: 12 weeks
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