Fecal microbiome of donor and recipient will be analyzed before and after fecal microbiota transplantation in IBD patients.
Fecal microbiota transplantation will be performed to the IBD patients, and microbial analysis will be done for donor and recipient feces. Fecal microbiota transplantation will be done twice via colonoscopy, with one month of duration. During the early stage of Fecal microbiota transplantation, recipient feces will be analyzed for the intestinal microbiota frequently. Clinical outcome will be assessed 1month, 2month, 6month, and 1 year after the transplantation. Relevance of intestinal microbial change and clinical outcome after transplantation and factors associated with successful clinical outcome will be investigated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Fecal microbiota transplantation will be performed through colonoscopy to the IBD patients. Donor feces will be extensively screened for other diseases. Colonoscopy will be done at FMT center of Severance Children's Hospital twice with a month of duration. Recipients will be admitted the day before colonoscopy, and they will be discharged after a day of observation.
Severance hospital
Seoul, South Korea
RECRUITINGClinical remission
For Ulcerative Colitis patients Patients 18 years old and under: Pediatric ulcerative colitis activity index (PUCAI) less than 10. It ranges from 0 to 85, with a higher score indicating greater severity of disease Patients over 18 years old: Partial Mayo score same or less than 1 It ranges from 0 to 9, with a higher score indicating greater severity of disease For Crohn's Disease patients Patients 18 years old and under: Pediatric Crohn's disease activity index (PCDAI) less than 10 It ranges from 0 to 100, with a higher score indicating greater severity of disease Patients over 18 years old: Crohn's disease activity index (CDAI) less than 150 It ranges from 0 to over 600, with a higher score indicating greater severity of disease
Time frame: 6months after the Second FMT
Microbiome analysis by using relative abundance at phylum and genus level, beta diversity
* Microbial changes (increase of microbial diversity and improvement of firmicutes/bacteriodes ratio) in an early stage after FMT by using Relative abundance at phylum and genus level * Microbial stability after FMT for one week (change in beta diversity)
Time frame: Before, day 0~28 of 1st FMT, day 0~28, 60, 90, 180 of 2nd FMT
Clinical response using disease activity index
Time frame: 6 months after the Second FMT
Endoscopic healing
Time frame: 4 weeks after the First FMT
Adverse events
Any adverse events thought to be related to FMT will be measured throughout the follow-up period after FMT.
Time frame: 6 months after the Second FMT
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